Randomised Prevention Trial of H. Pylori Screening

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

[2 paragraphs unchanged] The GDPR lawful basis for City St George’s, University of London to [38 words unchanged] The justification for relying on GDPR Articles 6(1)(e) and 9(2)(j) is because CSGUL is SGUL are a research university and this study will be able to determine if [29 words unchanged] it, many deaths from stomach cancer will be prevented in the future. The randomised controlled trial was originally set up at Queen Mary University of London (QMUL) Recruitment for the trial was from 1997 to 2006 during which 62,454 people attended ten BUPA Wellness Centres (for clarity , BUPA are not funding nor participating in this research, have no control over the purpose for processing, and will not have access to any record-level data) for a medical examination and were randomly allocated into screened and control groups. Eligibility for recruitment was restricted to individuals attending any of the ten BUPA Wellness Centres and was based on men aged 35 to 69 years and women aged 45 to 69 years. The age difference was due to concern about including pregnant women in the study and therefore it was decided to restrict the age range for women. Those with a past history of cancer or gastric surgery were excluded. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were subsequently flagged with NHS England and information on their deaths and cancer notifications has been supplied to the Principal Investigator at City St George’s, University of London since 1997 until 2024. A randomised controlled trial was originally set up at Queen Mary University of London (QMUL) which was concerned with screening and who decided that a large scale screening trial was needed to establish if population screening for H pylori and treating the infection would reduce the risk of stomach cancer. It was expected that the length of follow-up would be a minimum of 20 years. In 2020, the study team had some personnel changes and the study was transferred from QMUL to SGUL. The data was moved from QMUL to SGUL and is stored on secure password protected network drive based at SGUL. The data held at QMUL was deleted from their servers. Data Destruction certificates have been provided to NHS England to reflect the data move from QMUL to SGUL. An amendment has been submitted to move the data to the Secure eResearch Platform (SeRP UK), hosted by Swansea University. The data will be analysed at SGUL by remotely accessing it. No one from Swansea University will have access to the data. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attended ten BUPA Wellness Centres (for clarity , BUPA are not funding nor participating in this research, have no control over the purpose for processing, and will not have access to any record-level data) for a medical examination and were randomly allocated into screened and control groups. Eligibility for recruitment was restricted to individuals attending any of the ten BUPA Wellness Centres and was based on men aged 35 to 69 years and women aged 45 to 69 years. The age difference is due to concern about including pregnant women in the study and therefore it was decided to restrict the age range for women. Those with a past history of cancer or gastric surgery were excluded. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were subsequently flagged with NHS England and information on their deaths and cancer notifications has been supplied to the Principal Investigator at City St George’s, University of London since 1997 until 2020. It was expected that the length of follow-up would be a minimum of 20 years. In 2020, the study team had some personnel changes and the study was transferred from QMUL to SGUL. The data was moved from QMUL to SGUL and is stored on secure password protected network drive based at SGUL. The data held at QMUL was deleted from their servers. Data Destruction certificates have been provided to NHS England to reflect the data move from QMUL to SGUL. [3 paragraphs unchanged] c)The data processor of the record level data supplied by NHS England is the Secure eResearch Platform (SeRP UK), hosted by Swansea University. c) Only the named researchers City St George’s, University of London will have access to the record level data supplied by NHS England. d) Only the named researchers City St George’s, University of London will have access to is now the record level sole data held within SeRP UK. controller who also process the data for the purposes described . [5 paragraphs unchanged] When the dataset has accumulated enough data, for the results of the trial to have sufficient statistical power, the serum samples from all persons who developed stomach cancer or oesophageal cancer, and a random sample of those who did not, will be retrieved from freezers and tested for H pylori. The final comparison will be between the incidence of stomach or oesophageal cancer in the screened and control groups among H pylori positive persons only (rather than all persons). It is estimated that the study will obtain sufficient statistical power during 2022. [4 paragraphs unchanged] The study has not carried out any patient and public involvement and engagement (PPIE). The study has not yet carried out any patient and public involvement and engagement (PPIE) whilst the study continues to obtain statistical power. Once sufficient data has been obtained, the data controller will commit to identifying a non-medical person experienced in health care services to convene a lay panel (with public engagement) to advise and guide the principal investigators on matters relating to the dissemination of the results of the trial.

Processing activities

The HPSS trial started recruiting on 08/07/1997 and finished recruiting on 31/01/2006. Information for [13 words unchanged] of the trial cohort (n=62,454) have already been identified by NHS England. Information on deaths, demographic and cancer registrations on only these participants has been received electronically up to October 2024. This application is for permission to analyse the data currently stored and for additional events since October 2024 to be provided for: City St George’s, University of London originally submitted the following identifiers to NHS England in order to trace participants within the requested datasets. However, City St George’s, University of London have continued with the following identifiers: - Cancer Registrations • Study ID - Civil Registration Deaths • NHS Number - Demographics • Date Of Birth The data containing confidential identifiable information had been downloaded from the Secure Electronic File Transfer system (SEFT) onto a secure password protected network drive based at City St George’s, University of London and accessible only to the PI. The data were then linked with the data in the HPSS study database stored on the drive. Due to changes in IT capacity an amendment has been submitted to move the data to the Secure eResearch Platform (SeRP UK), hosted by Swansea University. The data will be downloaded from the SEFT onto a secure password protected network drive based at City St George’s, University of London and then transferred the same day to the SeRP UK. The data will be analysed at SGUL by remotely accessing it. No one from Swansea University will have access to the data. • Surname The information received from NHS England is stored with no changes to the files. Once the information is linked to the cases in the HPSS study database, the clinical information is stored in a dataset that does not include the identifiers, only the study IDs. A minimum data set for analysis will be created and exported from SeRP to be stored on the CSGUL secure server containing : • Forename Variables in Data: • Gender 1. BUPA_No – unique identifier The following data from NHS England will be disseminated during the Agreement; 2. Trial_Arm – screened, offered screening, accepted screening, screen positive - Cancer Registration-annually 3. Gender (m/f) - Civil Registration Deaths- annually 4. Age at screening in years - Demographics-annually 5. Length of time in study in days In summary: All 62,454 participants in the HPSS have been flagged at NHS England. Information on deaths, demographic and cancer registrations on only these participants is received once a year electronically. The data containing confidential identifiable information will be downloaded from the Secure Electronic File Transfer system (SEFT) onto a secure password protected network drive based at City St George’s, University of London and accessible only to the PI. The data are then linked with the data in the HPSS study database stored on the drive. De-identified information on the numbers of deaths and cancer will be reported. Data is only requested for those participants in the HPSS study. 6. Death during study (yes/no) • The information received from NHS England is stored with no changes to the files. Once the information is linked to the cases in the HPSS study database, the clinical information is stored in a dataset that does not include the identifiers, only the study IDs. All data is currently stored with identifiers and clinical data kept separately. A minimum data set for analysis will be created containing: 7. Any cancer diagnoses during time in study (yes/no) • Study ID 8. Diagnosis gastric cancer – Cardia, non-cardia or gastro oesophageal junction • Gender 9. Diagnosis oesophageal cancer – Oesophageal adenocarcinoma, oesophageal squamous cell, other oesophageal • Year of birth 10. Length of time from screening till diagnosis of any cancer (days) • Year when screened 11. Length of time from screening till diagnosis of gastric cancer (days) • Year when died or year when left study 12. Length of time from screening till diagnosis of oesophageal cancer (days) • Age at screening (completed years) 13. H Pylori measurement at screening • Age at death (completed years) The BUPA numbers from all cases of gastric or oesophageal cancer notified by October 2024in the minimum analytic data were used to identify the stored serum samples which have been retrieved from the freezers at City St Georges, University of London and their H Pylori infection status measured. Once additional cases of gastric or oesophageal cancer are provided from NHS England these too will be used to identify their stored serum samples to enable their H Pylori infection status to be measured. • Trial arm of study participant This pseudonymised data set will be analysed by the Principal Investigator and the results will be reported to Professor Nicholas Wald. This data will not have small number suppression applied. Professor Wald has been awarded the Honorary title and status of Visiting Professor based at the Population Health Research Institute (PHRI) at City St George's, University of London. • H Pylori status at screening • Cause of Death (all variables including ICD10 codes and text fields) • Cancer Site • Cancer Type This pseudonymised data set will be analysed by the Principal Investigator to determine the numbers of deaths and cancers and the results will be reported to Professor Nicholas Wald. This data will not have small number suppression applied. Professor Wald has been awarded the Honorary title and status of Visiting Professor based at the Population Health Research Institute (PHRI) at City St George's, University of London. Identifiable Data can currently only be accessed by the Principal Investigator. [2 paragraphs unchanged] Some identifiers are necessary to ensure that the correct match with the study participant is made. The BUPA identifiers which were used in this study were not totally unique, causing manual checks to be made when any linkage is performed. All identifiers are stored on a secure password protected network drive based at City St George’s, University of London. In addition the pseudonymised clinical dataset is also stored on the network drive. Both datasets are kept separate and the PI is the only person able to access the data. City St George’s, University of London retain the identifiers so as to double check that correct matches have been made especially for all stomach cancer cases. This is retained for validation only and controls will be in place to delete these once they are not necessary. [1 paragraph unchanged]

Expected output

Sufficient numbers of stomach and oesophageal cancers have been reported and their stored serum samples have been identified and analysed identified. The plan is to analyse these stored samples for the presence of H Pylori using an ELISA kit for the detection of human IgG antibodies to H. pylori in EDTA plasma. A The researchers have reached out to researchers at International Agency for Research on Cancer (IARC) for advice on the analysis of the stored samples. Once the analysis of serum samples has been performed and the statistical analysis completed a peer review paper analysing the results from the trial is being drafted. However, these results will be improved if additional cases of stomach and oesophageal cancers that have been reported since October 2024 are included. The paper will be submitted to an open-access peer reviewed journal. The target date for this is within 2026. one year of sufficient cancers having been reported. This paper should be influential in deciding whether to screen for H pylori infection. The final report of results will also be submitted to Cancer Research UK (CRUK). This will cover all findings of the study. The researchers will work with CRUK to provide a patient-friendly explanation of the research findings. It is hoped that our collaborators at IARC will also provide us with advice on dissemination of the results. [1 paragraph unchanged] A privacy notice is available on the City St George's University of London website: [1 paragraph unchanged] Depending on the outcome of the study, a discussion paper for consideration will be prepared in order to start discussions around implementation of a population screening programme, as well as measures to treat H pylori infections. [1 paragraph unchanged]

Expected measurable benefits

If the trial determines that screening and subsequent eradication of H pylori reduces the incidence of stomach cancer this would have an enormous benefit to the whole population in the UK and worldwide. Both screening and eradication (a 1-week course of antibiotics) are simple and cheap. Around 40% of people have H pylori infection. In 2022 6,034 2015, 6,740 people developed stomach cancer. If screening does work and prevents 20% of stomach cancers then this could mean that over 1,200 1,300 stomach cancers may be prevented per year. With 4 out of 10 [11 words unchanged] 40% of the population could have their risk of stomach cancer reduced. A reduction in incidence for oesophageal cancer would be very important, as this would be the first trial to have sufficient power to investigate whether H pylori eradication also reduces the risk of oesophageal cancer. The renewal of the data sharing agreement and hence additional stomach and oesophageal cancer cases would therefore enable the research team to obtain more accurate estimates enough information about cases of stomach cancer to provide the information needed on the value of screening. It is expected that this trial could provide evidence concerning whether screening and treatment for H pylori infection is worthwhile. If the results from the trial are positive then SGUL would be in a position to contact UK HSA to discuss implementing a population screening programme, as well as treatment options.

Benefits reported

As outlined in the study protocol it It is expected that the data will have matured around 15 years after [13 words unchanged] start being analysed for the purpose of producing a benefit to health. Sufficient cancers and deaths have now been reported (October 2022). (November 2024). The serum samples for the relevant deaths have been identified in the freezers and we are currently in the process of applying for permissions to analyse them (The methods of analysis have tested them for H pylori infection changed since the study protocol was written and therefore additional permissions are required). Once the serum samples have been analysed the results. We plan it is expected it will take up to submit 1 year to write a paper on the results and submit it for publication in a peer reviewed journal by the end of 2026. This paper would be improved if the additional deaths and cancers from October 2022 onwards could be included journal. At present, only a draft paper has been produced. At present, no outputs have been produced as of yet.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: + CITY ST GEORGE’S, UNIVERSITY OF LONDON · − ST. GEORGE’S HOSPITAL MEDICAL SCHOOL

Objective for processing

[1 paragraph unchanged] The Data Controller for this study is St George’s University Hospital Medical School who also processes the data. Whilst the Data Controller is legally named St George’s University Hospital Medical School, they are also known as St George's, University Hospital of London (SGUL). The Data Controller for this study is City St George’s, University of London. The GDPR lawful basis for SGUL City St George’s, University of London to process this data is Article 6(1)(e) 'task in the public interest' [27 words unchanged] The justification for relying on GDPR Articles 6(1)(e) and 9(2)(j) is because SGUL are CSGUL is a research university and this study will be able to determine if [29 words unchanged] it, many deaths from stomach cancer will be prevented in the future. A randomised controlled trial was originally set up at the Queen Mary University of London (QMUL) which was concerned with screening and who decided that a large scale screening trial was needed to establish if population screening for H pylori and treating the infection would reduce the risk of stomach cancer. The randomised controlled trial was originally set up at Queen Mary University of London (QMUL) Recruitment for the trial was from 1997 to 2006 during which 62,454 people attended ten BUPA Wellness Centres (for clarity , BUPA are not funding nor participating in this research, have no control over the purpose for processing, and will not have access to any record-level data) for a medical examination and were randomly allocated into screened and control groups. Eligibility for recruitment was restricted to individuals attending any of the ten BUPA Wellness Centres and was based on men aged 35 to 69 years and women aged 45 to 69 years. The age difference was due to concern about including pregnant women in the study and therefore it was decided to restrict the age range for women. Those with a past history of cancer or gastric surgery were excluded. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were subsequently flagged with NHS England and information on their deaths and cancer notifications has been supplied to the Principal Investigator at City St George’s, University of London since 1997 until 2024. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attended ten BUPA Wellness Centres (for clarity , BUPA are not funding nor participating in this research, have no control over the purpose for processing, and will not have access to any record-level data) for a medical examination and were randomly allocated into screened and control groups. Eligibility for recruitment was restricted to individuals attending any of the ten BUPA Wellness Centres and was based on men aged 35 to 69 years and women aged 45 to 69 years. The age difference is due to concern about including pregnant women in the study and therefore it was decided to restrict the age range for women. Those with a past history of cancer or gastric surgery were excluded. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were subsequently flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the Principal Investigator at QMUL since 1997 until 2020. It was expected that the length of follow-up would be a minimum of 20 years. In 2020, the study team had some personnel changes and the study was transferred from QMUL to SGUL. The data was moved from QMUL to SGUL and is stored on secure password protected network drive based at SGUL. The data held at QMUL was deleted from their servers. Data Destruction certificates have been provided to NHS England to reflect the data move from QMUL to SGUL. An amendment has been submitted to move the data to the Secure eResearch Platform (SeRP UK), hosted by Swansea University. The data will be analysed at SGUL by remotely accessing it. No one from Swansea University will have access to the data. It was expected that the length of follow-up would be a minimum of 20 years. In 2020, the study team had some personnel changes and the study was transferred from QMUL to SGUL. The data was moved from QMUL to SGUL and stored in the Data Safe Haven. The data held at QMUL was deleted from their servers. Data Destruction certificates have been provided to NHS Digital to reflect the data move from QMUL to SGUL. [2 paragraphs unchanged] b) BUPA Wellness Centres were approached to recruit patients; however, they are not processing any data from NHS Digital England or determine the purpose for processing. c) Only the named researchers at the Population Health Research Institute in SGUL will have access to the record level data supplied by NHS Digital. c)The data processor of the record level data supplied by NHS England is the Secure eResearch Platform (SeRP UK), hosted by Swansea University. d) SGUL is now the sole data controller who also process the data for the purposes described . d) Only the named researchers City St George’s, University of London will have access to the record level data held within SeRP UK. In this Agreement, (SGUL) require cancer notification, Demographic and mortality extracts, for use in Follow Up of participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS). Cancer type and site - needed to identify the exact cancer Cancer type and site anniversary year - SGUL need needed to identify know when the exact cancer was diagnosed Cancer anniversary year - SGUL need to know when the cancer was diagnosed Cause of death - all fields - needed to know cause of death and if cancer was mentioned on the death certificate Cause of death - all fields - SGUL need to know cause of death and if cancer was mentioned on the death certificate Event details - when City St George's, University of London have sufficient data from a set number of trial participants that would allow City St George's, University of London to gain analysis from the data. Event details - when SGUL have sufficient data from a set number of trial participants that would allow SGUL to gain analysis from the data. [1 paragraph unchanged] When the dataset has accumulated enough data, for the results of the trial to have sufficient statistical power, the serum samples from all persons who developed stomach cancer and a random sample of those who did not, or oesophageal cancer, will be retrieved from freezers and tested for H pylori. The final comparison will be between the incidence of stomach or oesophageal cancer in the screened and control groups among H pylori positive persons only (rather than all persons). It is estimated that the study will obtain sufficient statistical power during 2022. This study continues to collect data on the study participants relying on the randomisation in order to provide a definitive answer without the need to adjust for any con founders. confounders. Data is only requested for those participants in the HPSS study. [3 paragraphs unchanged] The study has not yet carried out any patient and public involvement and engagement (PPIE) whilst the study continues to obtain statistical power. Once sufficient data has been obtained, the data controller will commit to identifying a non-medical person experienced in health care services to convene a lay panel (with public engagement) to advise and guide the principal investigators on matters relating to the dissemination of the results of the trial. The study has not carried out any patient and public involvement and engagement (PPIE). The study is currently being funded by a personal budget by the previous PI, Professor Sir N J Wald, but hopes to secure other funding once analyses are underway.

Processing activities

The HPSS trial started recruiting on 08/07/1997 and finished recruiting on 31/01/2006. Information for linkage was submitted to NHS Digital, England, during this time period and all members of the trial cohort (n=62,454) have already been identified by NHS Digital. England. QMUL originally submitted the following identifiers to NHS Digital in order to trace participants within the requested datasets. However, SGUL have continued with the following identifiers: Information on deaths, demographic and cancer registrations on only these participants has been received electronically up to October 2024. This application is for permission to analyse the data currently stored and for additional events since October 2024 to be provided for: • Study ID - Cancer Registrations • NHS Number - Civil Registration Deaths • Date Of Birth - Demographics • Surname The data containing confidential identifiable information had been downloaded from the Secure Electronic File Transfer system (SEFT) onto a secure password protected network drive based at City St George’s, University of London and accessible only to the PI. The data were then linked with the data in the HPSS study database stored on the drive. Due to changes in IT capacity an amendment has been submitted to move the data to the Secure eResearch Platform (SeRP UK), hosted by Swansea University. The data will be downloaded from the SEFT onto a secure password protected network drive based at City St George’s, University of London and then transferred the same day to the SeRP UK. The data will be analysed at SGUL by remotely accessing it. No one from Swansea University will have access to the data. • Forename The information received from NHS England is stored with no changes to the files. Once the information is linked to the cases in the HPSS study database, the clinical information is stored in a dataset that does not include the identifiers, only the study IDs. A minimum data set for analysis will be created and exported from SeRP to be stored on the CSGUL secure server containing : • Gender Variables in Data: The following data from NHS Digital will be disseminated during the Agreement; 1. BUPA_No – unique identifier - Cancer Registration-quarterly 2. Trial_Arm – screened, offered screening, accepted screening, screen positive - Civil Registration Deaths- quarterly 3. Gender (m/f) - Demographics-quarterly 4. Age at screening in years In summary: All 62,454 participants in the HPSS have been flagged at NHS Digital. Information on deaths, demographic and cancer registrations on only these participants is received every 3 months electronically. The data containing confidential identifiable information will be downloaded from the Secure Electronic File Transfer system (SEFT) into the DASH (Data Access Secure Safe Haven) based at SGUL. The data are then linked with the data in the HPSS study database stored also within DASH. De-identified information on the numbers of deaths and cancer will be reported. Data is only requested for those participants in the HPSS study. 5. Length of time in study in days • The information received from NHS Digital is stored in DASH with no changes to the files. Once the information is linked to the cases in the HPSS study database, the clinical information is stored in a dataset that does not include the identifiers, only the study IDs. All data is currently stored within DASH with identifiers and clinical data kept separately. A minimum data set for analysis will be created containing : 6. Death during study (yes/no) • Study ID 7. Any cancer diagnoses during time in study (yes/no) • Gender 8. Diagnosis gastric cancer – Cardia, non-cardia or gastro oesophageal junction • Year of birth 9. Diagnosis oesophageal cancer – Oesophageal adenocarcinoma, oesophageal squamous cell, other oesophageal • Year when screened 10. Length of time from screening till diagnosis of any cancer (days) • Year when died or year when left study 11. Length of time from screening till diagnosis of gastric cancer (days) • Age at screening (completed years) 12. Length of time from screening till diagnosis of oesophageal cancer (days) • Age at death (completed years) 13. H Pylori measurement at screening • Trial arm of study participant The BUPA numbers from all cases of gastric or oesophageal cancer notified by October 2024in the minimum analytic data were used to identify the stored serum samples which have been retrieved from the freezers at City St Georges, University of London and their H Pylori infection status measured. Once additional cases of gastric or oesophageal cancer are provided from NHS England these too will be used to identify their stored serum samples to enable their H Pylori infection status to be measured. • H Pylori status at screening This pseudonymised data set will be analysed by the Principal Investigator and the results will be reported to Professor Nicholas Wald. This data will not have small number suppression applied. Professor Wald has been awarded the Honorary title and status of Visiting Professor based at the Population Health Research Institute (PHRI) at City St George's, University of London. • Cause of Death (all variables including ICD10 codes not text fields) There will be no data linkage undertaken with NHS England data provided under this Agreement that is not already noted in the Agreement. • Cancer Site (ICD10 codes not text fields) This pseudonymised data set will be analysed by the Principal Investigator or by a researcher once they are appointed to determine the numbers of deaths and cancers and the results will be reported to the PI and Professor Nicholas Wald. This data will not have small number suppression applied. Professor Wald has been awarded the Honorary title and status of Visiting Professor based at the Population Health Research Institute (PHRI) at SGUL. The Honorary appointment is effective from 8/4/2019-31/12/2022 with further extensions determined by SGUL. Identifiable Data can currently only be accessed by the Principal Investigator. At present there is no researcher on the study and so only the PI has access to the identifiable data. SGUL have identified funding and are planning to employ a researcher to update the database and so the researcher will need full access to the identifiable data once in post. The researcher will be expected to be substantively employed by SGUL before accessing the data. Any other researchers recruited at SGUL will only have access to the pseudonymised clinical data stored in DASH. Likewise, all additional researchers will be expected to be either substantively employed by SGUL or have an honorary contract in place before accessing the data. All organisations party to this Agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees of SGUL situated in the Population Health Research Institute who may have access to that data). There will be no data linkage undertaken with NHS Digital data provided under this Agreement that is not already noted in the Agreement. [1 paragraph unchanged] Some identifiers are necessary to ensure that the correct match with the study participant is made. The BUPA identifiers which were used in this study were not totally unique, causing manual checks to be made when any linkage is performed. All identifiers are stored in the DASH at SGUL. In addition the pseudonymised clinical dataset is also stored in the DASH. Both datasets are kept separate and has access restrictions applied. Data will only be accessed and processed by substantive employees of City St George’s, University of London (or have an honorary contract in place with City St George’s, University of London) and will not be accessed or processed by any other third parties not mentioned in this Agreement. SGUL retain the identifiers so as to double check that correct matches have been made especially for all stomach cancer cases. This is retained for validation only and controls will be in place to delete these once they are not necessary. Data will only be accessed and processed by substantive employees of SGUL (or have an honorary contract in place with SGUL) and will not be accessed or processed by any other third parties not mentioned in this Agreement.

Expected output

As soon as a suitable researcher with approved researcher status is appointed, regular reports on the numbers of stomach cancers, oesophageal cancers, deaths from Ischemic heart disease and deaths from all causes will be reported to the researchers working on the HPylori study. This will be de-identified pseudonymised data provided to the PI and associated researchers. Sufficient numbers of stomach cancers have been reported and their stored serum samples have been identified and analysed for the presence of H Pylori using an ELISA kit for the detection of human IgG antibodies to H. pylori in EDTA plasma. A peer review paper analysing the results from the trial is being drafted. However, these results will be improved if additional cases of stomach and oesophageal cancers that have been reported since October 2024 are included. The paper will be submitted to an open-access peer reviewed journal. The target date for this is within 2026. This paper should be influential in deciding whether to screen for H pylori infection. The study's aim of analysing the serum samples to determine if screening for and subsequently treating HPylori infection reduces the risk of developing stomach cancer is unaltered. Once the numbers of stomach cancers have occurred, SGUL are planning to analyse the serum samples of the people who have died from stomach cancers all at the same time. The study maintains pages on the Medical Screening Society website which is available to the general public including the participants of the study: https://www.medicalscreeningsociety.com/CurrentTrials.asp The analysis will occur when there have been more than 120 stomach cancers reported so that SGUL can analyse a small sample of cases rather than 56,000. Once the analysis of serum samples has been performed and the statistical analysis completed a peer review paper analysing the results from the trial will be submitted to an open-access peer reviewed journal. The target date for this is within one year of sufficient cancers having been reported. This paper should be influential in deciding whether to screen for H pylori infection. The final report of results will also be submitted to Cancer Research UK (CRUK). This will cover all findings of the study. The researchers will work with CRUK to provide a patient-friendly explanation of the research findings. The study also maintains a website which is available to the general public including the participants of the study – https://www.sgul.ac.uk/about/our-professional-services/information-services/information-governance/documents/privacy-notices/20200106-Privacy-Notice-HPylori.pdf. A privacy notice is available on the City St George's University of London website: Depending on the outcome of the study, a discussion paper for consideration will be prepared in order to start discussions around implementation of a population screening programme, as well as measures to treat H pylori infections. https://www.sgul.ac.uk/about/our-professional-services/information-services/information-governance/documents/privacy-notices/20200106-Privacy-Notice-HPylori.pdf. [1 paragraph unchanged]

Expected measurable benefits

If the trial determines that screening and subsequent eradication of H pylori reduces the incidence of stomach cancer this would have an enormous benefit to the whole population in the UK and worldwide. Both screening and eradication (a 1-week course of antibiotics) are simple and cheap. Around 40% of people have H pylori infection. In 2015, 6,740 2022 6,034 people developed stomach cancer. If screening does work and prevents 20% of stomach cancers then this could mean that over 1,300 1,200 stomach cancers may be prevented per year. With 4 out of 10 [11 words unchanged] 40% of the population could have their risk of stomach cancer reduced. A reduction in incidence for oesophageal cancer would be very important, as this would be the first trial to have sufficient power to investigate whether H pylori eradication also reduces the risk of oesophageal cancer. The renewal of the data sharing agreement and hence additional stomach and oesophageal cancer cases would therefore enable the research team to obtain enough information about cases more accurate estimates of stomach cancer to provide the information needed on the value of screening. It is expected that this trial could provide evidence concerning whether screening and treatment for H pylori infection is worthwhile. If the results from the trial are positive then SGUL would be in a position to contact UK HSA to discuss implementing a population screening programme, as well as treatment options.

Benefits reported

As outlined in the study protocol it is expected that the data [19 words unchanged] then start being analysed for the purpose of producing a benefit to Health. This is expected to be during 2022. health. At present, no outputs have been produced as of yet. Sufficient cancers and deaths have now been reported (October 2022). The serum samples for the relevant deaths have been identified in the freezers and we have tested them for H pylori infection and analysed the results. We plan to submit a paper for publication in a peer reviewed journal by the end of 2026. This paper would be improved if the additional deaths and cancers from October 2022 onwards could be included At present, only a draft paper has been produced.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

Helicobacter pylori (H pylori) infection of the stomach accounts for most cases of stomach cancer worldwide. [30 words unchanged] treatment of the infection in middle age can reverse this excess risk. This trial aims to determine if screening for and treating H Pylori infection in middle age reduces the risk of stomach cancer Researchers at the Wolfson Institute, QMUL were concerned with screening and decided that a large scale screening trial was needed to establish if population screening for H pylori and treating the infection would reduce the risk of stomach cancer. The Data Controller for this study is St George’s University Hospital Medical School who also processes the data. Whilst the Data Controller is legally named St George’s University Hospital Medical School, they are also known as St George's, University Hospital of London (SGUL). A randomised controlled trial was set up to answer this question. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attending ten BUPA Wellness Centres (for clarity, BUPA are not funding nor participating in this research, have no control over any processing, and will not have access to any record-level data) for a medical examination were randomly allocated into screened and control groups. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the PI at QMUL since 1997. It was expected that the length of follow-up would be a minimum of 20 years. The GDPR lawful basis for SGUL to process this data is Article 6(1)(e) 'task in the public interest' , and Article 9(2)(j) ` necessary for archiving purposes in the public interest, or scientific and historical research purposes or statistical purposes in accordance with Article 89(1)'. The justification for relying on GDPR Articles 6(1)(e) and 9(2)(j) is because SGUL are a research university and this study will be able to determine if treatment of H pylori can decrease risk of cancer in later life. If this trial demonstrates screening is worthwhile and the national screening committee can be persuaded to adopt it, many deaths from stomach cancer will be prevented in the future. The PI retired in 2019 and the new PI has moved from QMUL to Population Health Research Institute, St George's, University of London. MREC approval has been obtained to move the study to SGUL. From the end of 2019, SGUL will be the sole data controller and the only organisation processing data for this study under this data sharing agreement. No other organisation will have responsibility for making decisions about the purposes for which this data is processed, or the manner in which it is processed. A randomised controlled trial was originally set up at the Queen Mary University of London (QMUL) which was concerned with screening and who decided that a large scale screening trial was needed to establish if population screening for H pylori and treating the infection would reduce the risk of stomach cancer. St George's University of London (SGUL) require cancer notification and death certificates for use in Follow Up of participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS). Recruitment for the trial was from 1997 to 2006 during which 62,454 people attended ten BUPA Wellness Centres (for clarity , BUPA are not funding nor participating in this research, have no control over the purpose for processing, and will not have access to any record-level data) for a medical examination and were randomly allocated into screened and control groups. Eligibility for recruitment was restricted to individuals attending any of the ten BUPA Wellness Centres and was based on men aged 35 to 69 years and women aged 45 to 69 years. The age difference is due to concern about including pregnant women in the study and therefore it was decided to restrict the age range for women. Those with a past history of cancer or gastric surgery were excluded. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were subsequently flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the Principal Investigator at QMUL since 1997 until 2020. It was expected that the length of follow-up would be a minimum of 20 years. In 2020, the study team had some personnel changes and the study was transferred from QMUL to SGUL. The data was moved from QMUL to SGUL and stored in the Data Safe Haven. The data held at QMUL was deleted from their servers. Data Destruction certificates have been provided to NHS Digital to reflect the data move from QMUL to SGUL. [1 paragraph unchanged] a) Researchers at the Wolfson Institute, Queen Mary University of London (QMUL) who instigated the trial b) BUPA Wellness Centres were approached to recruit patients; however, they are not processing any data from NHS Digital or determine the purpose for processing. [1 paragraph unchanged] When a sufficient number of participants have developed stomach cancer for the results of the trial to have sufficient statistical power the serum samples from all persons who developed stomach cancer and a random sample of those who did not will be retrieved from freezers and tested for H pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons). This design, a “nested randomised trial”, maximizes statistical power and substantially reduces cost. d) SGUL is now the sole data controller who also process the data for the purposes described . The GDPR lawful basis for SGUL to process this data is Article 6(1)(e) 'task in the public interest' and Article 9(2)(j) 'scientific or historical research purposes'. In this Agreement, (SGUL) require cancer notification, Demographic and mortality extracts, for use in Follow Up of participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS). Cancer type and site - SGUL need to identify the exact cancer Cancer anniversary year - SGUL need to know when the cancer was diagnosed Cause of death - all fields - SGUL need to know cause of death and if cancer was mentioned on the death certificate Event details - when SGUL have sufficient data from a set number of trial participants that would allow SGUL to gain analysis from the data. This study started recruiting in 1997 and since then minor discrepancies have been observed in the assigning of unique study identifiers. All notifications for deaths and cancers are therefore linked on study identifiers, and the linkage is checked using names and dates of birth. When the dataset has accumulated enough data, for the results of the trial to have sufficient statistical power, the serum samples from all persons who developed stomach cancer and a random sample of those who did not, will be retrieved from freezers and tested for H pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons). It is estimated that the study will obtain sufficient statistical power during 2022. This study continues to collect data on the study participants relying on the randomisation in order to provide a definitive answer without the need to adjust for any con founders. Data is only requested for those participants in the HPSS study. The Cancer data requested needs to include personal identifiers in order to ensure that the deaths and cancers are linked to the correct study participants. (Minor discrepancies in the BUPA study id’s have meant that linkages need to be confirmed using the personal identifiers). The information requested includes name, gender and date of birth, date of death, cause of death (all categories) and information on cancer notifications (date, site and type). Data on all cancers are required in order to confirm overall cancer rates for cancers not predicted to be associated with H Pylori infections. Any external output will be aggregated with small numbers suppressed. Therefore, there will be no risk of identifying any participants. The study has HRA approval reference 17/NW/0681. The study has not yet carried out any patient and public involvement and engagement (PPIE) whilst the study continues to obtain statistical power. Once sufficient data has been obtained, the data controller will commit to identifying a non-medical person experienced in health care services to convene a lay panel (with public engagement) to advise and guide the principal investigators on matters relating to the dissemination of the results of the trial. The study is currently being funded by a personal budget by the previous PI, Professor Sir N J Wald, but hopes to secure other funding once analyses are underway.

Processing activities

All 62,454 participants in the HPSS have been flagged at NHS Digital. Information on deaths and cancer registrations is requested to be received every 6 months electronically. The electronic information will be downloaded onto a secure server, protected by a fire-wall, based in St George's, University of London. The data are then merged with the HPSS study database in Population Health Research Institute, SGUL. The data are stored on the server, with any identifiers stored separately from the clinical information. The study statistician will only be provided with pseudonymised information on the numbers of deaths and cancer registrations that have occurred since the start of the trial. The trial started recruiting on 08/07/1997 and finished recruiting on 31/01/2006. Information for linkage was submitted to NHS Digital, during this time period and all members of the trial cohort (n=62,454) have already been identified by NHS Digital. Data will only be accessed by individuals within the PHRI, SGUL who have authorisation from the PI to access the data for the purpose described, all of whom are substantive employees of SGUL. QMUL originally submitted the following identifiers to NHS Digital in order to trace participants within the requested datasets. However, SGUL have continued with the following identifiers: The core dataset will only be accessed by the PI. The PI will produce subsets of the data that will be accessed by the study statistician. Any other person seeking access to a subset of the data will have to submit a formal request to the PI and justify from a scientific basis all requested information. • Study ID • NHS Number • Date Of Birth • Surname • Forename • Gender The following data from NHS Digital will be disseminated during the Agreement; - Cancer Registration-quarterly - Civil Registration Deaths- quarterly - Demographics-quarterly In summary: All 62,454 participants in the HPSS have been flagged at NHS Digital. Information on deaths, demographic and cancer registrations on only these participants is received every 3 months electronically. The data containing confidential identifiable information will be downloaded from the Secure Electronic File Transfer system (SEFT) into the DASH (Data Access Secure Safe Haven) based at SGUL. The data are then linked with the data in the HPSS study database stored also within DASH. De-identified information on the numbers of deaths and cancer will be reported. Data is only requested for those participants in the HPSS study. • The information received from NHS Digital is stored in DASH with no changes to the files. Once the information is linked to the cases in the HPSS study database, the clinical information is stored in a dataset that does not include the identifiers, only the study IDs. All data is currently stored within DASH with identifiers and clinical data kept separately. A minimum data set for analysis will be created containing : • Study ID • Gender • Year of birth • Year when screened • Year when died or year when left study • Age at screening (completed years) • Age at death (completed years) • Trial arm of study participant • H Pylori status at screening • Cause of Death (all variables including ICD10 codes not text fields) • Cancer Site (ICD10 codes not text fields) This pseudonymised data set will be analysed by the Principal Investigator or by a researcher once they are appointed to determine the numbers of deaths and cancers and the results will be reported to the PI and Professor Nicholas Wald. This data will not have small number suppression applied. Professor Wald has been awarded the Honorary title and status of Visiting Professor based at the Population Health Research Institute (PHRI) at SGUL. The Honorary appointment is effective from 8/4/2019-31/12/2022 with further extensions determined by SGUL. Identifiable Data can currently only be accessed by the Principal Investigator. At present there is no researcher on the study and so only the PI has access to the identifiable data. SGUL have identified funding and are planning to employ a researcher to update the database and so the researcher will need full access to the identifiable data once in post. The researcher will be expected to be substantively employed by SGUL before accessing the data. Any other researchers recruited at SGUL will only have access to the pseudonymised clinical data stored in DASH. Likewise, all additional researchers will be expected to be either substantively employed by SGUL or have an honorary contract in place before accessing the data. [1 paragraph unchanged] No further linkage will be performed. There will be no data linkage undertaken with NHS Digital data provided under this Agreement that is not already noted in the Agreement. The data will not be made available to any third parties except in the form of as aggregated outputs with small numbers suppressed suppressed, in line with the HES Analysis Guide. Data is only requested for those participants in the HPSS study. Some identifiers are necessary to ensure that the correct match with the study participant is made. The BUPA identifiers which were used in this study were not totally unique, causing manual checks to be made when any linkage is performed. All identifiers are stored in the DASH at SGUL. In addition the pseudonymised clinical dataset is also stored in the DASH. Both datasets are kept separate and has access restrictions applied. Some identifiers are necessary to ensure that the correct match with the study participant is made. The BUPA identifiers which were used in this study were not totally unique, causing manual checks to be made when any linkage is performed. SGUL retain the identifiers so as to double check that correct matches have been made especially for all stomach cancer cases. This is retained for validation only and controls will be in place to delete these once they are not necessary. No outputs have been produced as the data analysis plan was designed such that no analysis would be undertaken until sufficient numbers of stomach cancers had occurred. The numbers reported are not sufficient yet. Data will only be accessed and processed by substantive employees of SGUL (or have an honorary contract in place with SGUL) and will not be accessed or processed by any other third parties not mentioned in this Agreement.

Expected output

The following outputs will be produced : As soon as a suitable researcher with approved researcher status is appointed, regular reports on the numbers of stomach cancers, oesophageal cancers, deaths from Ischemic heart disease and deaths from all causes will be reported to the researchers working on the HPylori study. This will be de-identified pseudonymised data provided to the PI and associated researchers. A peer review paper analysing the results from the trial will be submitted to an open-access peer reviewed journal within one year after sufficient stomach cancers have occurred; as outlined in the Protocol, current estimates indicate that sufficient stomach cancers will have occurred sometime in 2021. This paper should be influential in deciding whether to screen for H pylori infection . The final report of results will be submitted to Cancer Research UK (CRUK). This will cover all findings of the study. The researchers will work with CRUK to provide a patient-friendly explanation of the research findings. The study's aim of analysing the serum samples to determine if screening for and subsequently treating HPylori infection reduces the risk of developing stomach cancer is unaltered. Once the numbers of stomach cancers have occurred, SGUL are planning to analyse the serum samples of the people who have died from stomach cancers all at the same time. For each paper published, a short presentation will be developed to summarise the findings for a range of stakeholders, including healthcare professionals and patient groups. In particular, depending on the outcome of the study, discussion papers for consideration by Public Health England will be prepared in order to start discussions around implementation of a population screening programme, as well as measures to treat H pylori infections. The analysis will occur when there have been more than 120 stomach cancers reported so that SGUL can analyse a small sample of cases rather than 56,000. Once the analysis of serum samples has been performed and the statistical analysis completed a peer review paper analysing the results from the trial will be submitted to an open-access peer reviewed journal. The target date for this is within one year of sufficient cancers having been reported. This paper should be influential in deciding whether to screen for H pylori infection. The final report of results will also be submitted to Cancer Research UK (CRUK). This will cover all findings of the study. The researchers will work with CRUK to provide a patient-friendly explanation of the research findings. The study also maintains a website which is available to the general public including the participants of the study – https://www.sgul.ac.uk/about/our-professional-services/information-services/information-governance/documents/privacy-notices/20200106-Privacy-Notice-HPylori.pdf. The study website will provide links to the open access papers and will offer free downloads of accessible summaries of findings. Depending on the outcome of the study, a discussion paper for consideration will be prepared in order to start discussions around implementation of a population screening programme, as well as measures to treat H pylori infections. All outputs Outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Expected measurable benefits

If the trial determines that screening and subsequent eradication of H pylori reduces the incidence of stomach cancer this will would have an enormous benefit to the whole population in the UK and [29 words unchanged] If screening does work and prevents 20% of stomach cancers then this will could mean that over 1,300 stomach cancers will may be prevented per year. With 4 out of 10 people in the [9 words unchanged] of the population could have their risk of stomach cancer reduced. The extension renewal of this the data sharing agreement will would therefore allow enable the research team to obtain enough information about cases of stomach cancer to provide the information needed on the value of screening. This It is expected that this trial will could provide evidence concerning whether screening and treatment for H pylori infection is [6 words unchanged] trial are positive then SGUL would be in a position to contact PHE UK HSA to discuss implementing a population screening programme, as well as treatment options.

Benefits reported

No outputs have been produced as the data analysis plan was designed such that no analysis would be undertaken until sufficient numbers of stomach cancers had occurred. The numbers reported are not sufficient yet: it is estimated that the required number will be reached in 2021. As outlined in the study protocol it is expected that the data will have matured around 15 years after the last participant has been recruited, in which case the data can then start being analysed for the purpose of producing a benefit to Health. This is expected to be during 2022. At present, no outputs have been produced as of yet.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Cancer Registration Data; + Civil Registrations of Death; + Demographics

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: + ST. GEORGE’S HOSPITAL MEDICAL SCHOOL · − QUEEN MARY UNIVERSITY OF LONDON

Objective for processing

[1 paragraph unchanged] The Wolfson Institute, QMUL requires cancer notification and death certificates for use in Follow Up of Participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS) Researchers at the Wolfson Institute, QMUL were concerned with screening and decided that a large scale screening trial was needed to establish if population screening for H pylori and treating the infection would reduce the risk of stomach cancer. a) Researchers at the Wolfson Institute, QMUL instigated the trial A randomised controlled trial was set up to answer this question. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attending ten BUPA Wellness Centres (for clarity, BUPA are not funding nor participating in this research, have no control over any processing, and will not have access to any record-level data) for a medical examination were randomly allocated into screened and control groups. Those screened were offered serological testing for H pylori and, if they were positive, a one-week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the PI at QMUL since 1997. It was expected that the length of follow-up would be a minimum of 20 years. b) BUPA Wellness Centres were approached to recruit patients The PI retired in 2019 and the new PI has moved from QMUL to Population Health Research Institute, St George's, University of London. MREC approval has been obtained to move the study to SGUL. From the end of 2019, SGUL will be the sole data controller and the only organisation processing data for this study under this data sharing agreement. No other organisation will have responsibility for making decisions about the purposes for which this data is processed, or the manner in which it is processed. c) Only the named researchers at the Wolfson Institute, QMUL will have access to the record level data supplied by NHS digital. St George's University of London (SGUL) require cancer notification and death certificates for use in Follow Up of participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS). Researchers at the Wolfson Institute are concerned with screening and decided that a large scale screening trial was needed to establish if population screening for HPylori and treating the infection would reduce the risk of stomach cancer . The organisations involved in this research have been: A randomised controlled trial was set up to answer this question. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attending ten BUPA Wellness Centres for a medical examination were randomly allocated into screened and control groups. Those screened were offered serological testing for H pylori and, if they were positive, a one week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the PI since 1997. It was expected that the length of follow-up would be a minimum of 20 years. a) Researchers at the Wolfson Institute, Queen Mary University of London (QMUL) instigated the trial When a sufficient number of participants have developed stomach cancer for the results of the trial to have sufficient statistical power the serum samples from all persons who developed stomach cancer and a random sample of those who did not will be retrieved from freezers in the Wolfson Institute and tested for H. pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons). This design, a “nested randomised trial”, maximizes statistical power and substantially reduces cost. b) BUPA Wellness Centres were approached to recruit patients; however, they are not processing any data from NHS Digital c) Only the named researchers at the Population Health Research Institute in SGUL will have access to the record level data supplied by NHS digital. When a sufficient number of participants have developed stomach cancer for the results of the trial to have sufficient statistical power the serum samples from all persons who developed stomach cancer and a random sample of those who did not will be retrieved from freezers and tested for H pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons). This design, a “nested randomised trial”, maximizes statistical power and substantially reduces cost. The GDPR lawful basis for SGUL to process this data is Article 6(1)(e) 'task in the public interest' and Article 9(2)(j) 'scientific or historical research purposes'.

Processing activities

All 62,454 participants in the HPSS have been flagged at NHS Digital. [19 words unchanged] be downloaded onto a secure server, protected by a fire-wall, based in the Wolfson Institute St George's, University of Preventive Medicine. London. The data are then merged with the HPSS study database by the database manager in the Wolfson Institute. Population Health Research Institute, SGUL. The data are stored on the server, with any identifiers stored separately from the clinical information. The database manager provides the study statistician will only be provided with pseudonymised information on the numbers of deaths and cancer registrations that have occurred since the start of the trial. Data will only be accessed by individuals within the Centre for Environmental and Preventive Medicine PHRI, SGUL who have authorisation from the PI (Sir Nicholas Wald) to access the data for the purpose described, all of whom are substantive employees of QMUL. SGUL. The core dataset will only be accessed by the data manager within the Wolfson Institute. They PI. The PI will produce subsets of the data that will be accessed by the study statistician. Any other person seeking access toi to a subset of the data will have to submit a formal reuest request to the PI (Sir Nicholas Wald) and justify from a scientific basis all requested information. All organisations party to this agreement must comply with the Data Sharing [14 words unchanged] “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees of QMUL SGUL situated in the Centre for Environmental and Preventive medicine Population Health Research Institute who may have access to that data). [1 paragraph unchanged] The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. [3 paragraphs unchanged]

Expected output

[1 paragraph unchanged] A peer review paper analysing the results from the trial will be submitted to an open-access peer reviewed journal within one year after sufficient stomach cancers have occurred.This occurred; as outlined in the Protocol, current estimates indicate that sufficient stomach cancers will have occurred sometime in 2021. This paper should be influential in deciding whether to screen for H Pylori pylori infection . The final report of results will be submitted to CRUK. Cancer Research UK (CRUK). This will cover all findings of the study. The researchers will work with CRUK to provide a patient-friendly explanation of the research findings. For each paper published, a short presentation may will be developed to summarise the findings for a range of stakeholders, including healthcare professionals and patient groups. In particular, depending on the outcome of the study, discussion papers for consideration by Public Health England will be prepared in order to start discussions around implementation of a population screening programme, as well as measures to treat H pylori infections. [1 paragraph unchanged] All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide/compliant with the MHSDS disclosure control rules including suppression and rounding. Guide.

Expected measurable benefits

If the trial determines that screening and subsequent eradication of H Pylori pylori reduces the incidence of stomach cancer this will have an enormous benefit to the whole population in the UK and worldwide. Both screening and eradication (a 1 week 1-week course of antibiotics) are simple and cheap. Around 40% of people have H Pylori pylori infection. In 2015 6740 2015, 6,740 people developed stomach cancer. If screening does work and prevents 20% of stomach cancers then this will mean that over 1,300 stomach cancers will be prevented. prevented per year. With 4 out of 10 people in the UK thought to have H Pylori pylori infection potentially 40% of the population could have their risk of stomach cancer reduced. The extension of our this data sharing agreement will therefore allow us the research team to obtain enough cases of stomach cancer to provide the information needed on the value of screening. This trial will provide evidence concerning whether screening and treatment for HPylori H pylori infection is worthwhile. If the results from the trial are positive then we SGUL would be in a position to contact PHE to discuss implementing a population screening programme. programme, as well as treatment options.

Benefits reported

No outputs have been produced as the data analysis plan was designed [9 words unchanged] numbers of stomach cancers had occurred. The numbers reported are not sufficient yet. yet: it is estimated that the required number will be reached in 2021.