Faecal Immunochemical Testing (FIT) for Adenoma Surveillance ( ODR_2014_293 )

The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London (ICL) aim to determine whether offering faecal immunochemical tests (FIT), once a year, to people who have been diagnosed with intermediate adenomas (one large or 3-4 small polyps detected at colonoscopy) in the NHS/(previously Public Health England (PHE) Bowel Cancer Screening Programme (BCSP) is an effective and safe alternative to the recommended 3-yearly follow-up colonoscopy.

ICL aim to:

- Determine the sensitivity of three annual FITs in the detection of advanced adenomas or early stage colorectal cancers compared with a 3-yearly colonoscopy.

- Determine the acceptability of FIT compared with colonoscopy as an alternative method of surveillance for people at an increased risk of colorectal cancer.

- Calculate if there are any potential cost increases or savings of FIT vs. colonoscopy surveillance (a health economic analysis).

The following data was previously disseminated by patient consent by The National Disease Registration Service (formally under Public Health England (PHE) in order to achieve these objectives:

- Identifiers (e.g. names, NHS numbers, gender, addresses) from PHE BCSP at study commencement

- PHE BCSP FIT results

- PHE BCSP colonoscopy surveillance data via NHS Digital

- NDRS Cancer Registration (cancer incidence and staging data)

Data disseminated covers the years 2012-2020 and limited to a consented cohort.

ICL rely on the follow legal basis' for processing these data:

- Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

- Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data

The national data opt-out does not apply where explicit consent has been obtained from the patient for the specific purpose.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

No further data will flow under this data sharing agreement. The purpose of this DSA is to allow ICL to continue processing data previously disseminated to them by The National Disease Registration Service (formally under Public Health England (PHE).

Historically, the CSPRG at ICL received from the PHE Bowel Cancer Screening Programme (BCSP) data under patient consent, the following identifiable/sensitive study cohort data:

a) Patient information (e.g. names, gender, addresses) to correctly match patients to their FIT results and other clinical data and to administer a patient health questionnaire. Data was stored and managed by a Patient Management System (PMS) held at the University of Southampton. This PMS was decommissioned with all data confirmed by University of Southampton as deleted on 15 October 2019. Prior to destruction of the PMS, a copy of the PMS data was extracted and sent to ICL.

b) Patient FIT results received via the PMS.

c) Patient colonoscopy surveillance information received via NHS Digital.

d) NCRAS/NDRS patient cancer incidence and staging data.

All identifiable information sent to and held by the CSPRG at ICL was received under patient consent.

In 2019, NHS number, date of birth and unique study IDs were sent by the CSPRG to the BCSP to identify the cohort in BCSP records and extract their baseline colonoscopy data.

Patient recruitment was achieved with the help of time-limited Section 251 support (ECC 3-04(p)/2011) for the disclosure of identifiable patient information for the purpose of seeking consent to participate in the study. The identification and invitation of eligible patients to take part in the study was conducted by the BCSP Southern Programme Hub. Patient recruitment began in February 2012 and was completed in December 2013.

The Data disseminated for this programme of work will not be transferred to any other location. The Data is stored on servers at ICL. The Data will remain on the servers at ICL at all times until the required deletion date. Data will be accessed onsite at ICL and via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this agreement) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England/Wales at any time.

Access is restricted to substantial employees of ICL and affiliated students of ICL who have authorisation from the Principal Investigator. All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data. Analysts/researchers from ICL will only process/analyse the Data for the purposes described above.

Update as per annual confirmation report 8 January 2024

The results of the FIT for Follow-Up study have been and will continue to be published in high-impact journals and at scientific conferences. The publication of the outcomes of this study in international journals will ensure that this data is available for future validation of the recommendations from the study and potential uptake into revised guidelines for surveillance.

The primary study outcomes were published in BMJ Gut in 2019: Cross AJ, Wooldrage K, Robbins EC, et al. Faecal immunochemical tests (FIT) versus colonoscopy for surveillance after screening and polypectomy: a diagnostic accuracy and cost-effectiveness study. Gut 2019;68:1642-1652. http://dx.doi.org/10.1136/gutjnl-2018-317297.

The data is currently helping secondary analyses including examining the variability in stool haemoglobin levels both within- and between-individuals and the consequential impact on FIT sensitivity and specificity. The study team hope to publish and disseminate secondary outcomes between 2024 and 2025.

All outputs contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Communication channels the CSPRG has utilised to proactively share study results directly with the public include:

- Study website https://csprg.org.uk/fit_for_follow-up/

- Dissemination of study outcomes and results via official CSPRG Twitter account @CSPRG_Imperial

- clinicians, gastroenterologists and research scientists at the British Society of Gastroenterology (BSG) Annual Meeting in Liverpool, UK, June 2018

The FIT for Follow-Up study aimed to find out whether annual Faecal Immunochemical Tests (FIT), which detect traces of blood in stool, are accurate enough to replace three-yearly colonoscopy (an examination of the inside of the bowel) in people who have previously had a large polyp, or a few small polyps, removed at colonoscopy. FITs are quicker, cheaper and easier than colonoscopy, which has risks of complications.

A total of 8,009 people were invited to participate in the study. Of those invited, 5,938 (74%) returned a signed consent form and completed a FIT at year one. Participation in the study was similar amongst men and women, and across age groups.

Among those completing a FIT at year one, the study team found that FIT was well-accepted with 97% of participants returning FIT kits at years two and three. Over the three years of the study, 786 (13%) participants tested FIT positive, of whom 582 (10%) tested positive at year one or two and were invited for colonoscopy earlier than usually scheduled.

Unless they had a colonoscopy early as a result of a positive FIT, all participants were invited to have a colonoscopy at the end of the study (after three years). Of the 5,938 participants, 5,225 had a colonoscopy at some time during the study. During the three years, bowel cancer was diagnosed in 29 participants and advanced adenomas were diagnosed in 446.

In total, 725 (12%) participants underwent a colonoscopy after a positive FIT result. Amongst these individuals, cancer was found in 17 and advanced adenomas in 151. FIT therefore identified 17 of 29 (59%) participants with cancer and 151 of 446 (34%) participants with advanced adenomas. The study team also performed analyses applying lower positivity thresholds and found that with the lowest positivity threshold applied, 72% of participants with cancer and 57% of participants with advanced adenomas were identified.

ICL also carried out analyses to determine how cost effective an annual FIT test was compared to three yearly colonoscopies and to investigate patients surveillance preferences. Annual FITs were considerably cheaper than three-year colonoscopy. Patients reported that the FIT was easy to use and provided reassurance. However, some were concerned that the FIT would not be as effective as colonoscopy. Continued research will help to define a clear role of FITs in surveillance.

The results of the FIT for Follow-Up study are available on the National Institute for Health Research (NIHR) website (https://www.journalslibrary.nihr.ac.uk/programmes/hta/0922192#/) and the NIHR Health Technology Assessment journal website (https://www.journalslibrary.nihr.ac.uk/hta/hta23010#/abstract). They were also published in the journal GUT in 2019 (https://gut.bmj.com/content/early/2018/12/11/gutjnl-2018-317297).

Overall, the study has so far demonstrated that annual FIT could identify 59 to 72 of every 100 cancers and 34 to 57 of every 100 patients with advanced adenomas if repeated over three years. The study team found that replacing three-yearly colonoscopy surveillance in intermediate-risk patients with annual FIT could reduce colonoscopies by 71% and significantly cut costs to the NHS, but certain cancers and adenomas could be missed.

To the study teams knowledge, this study is the only one to have evaluated FIT for monitoring people who have previously had a large polyp, or a few small polyps, removed at colonoscopy.