Evaluating the current standard of care for patients diagnosed with malignant melanoma of the head and neck – access to staging and surgical treatment. (ODR2122_2697)

Hull University Teaching Hospitals NHS Trust (HUTH) requires access to NHS England data for the purpose of the following research project:

Evaluating the current standard of care for patients diagnosed with malignant melanoma of the head and neck – access to staging and surgical treatment. (ODR2122_2697)

Melanoma is the 5th most common cancer in the UK and is treated by removing the cancer with an operation. Early spread can be detected through sampling of nearby lymph nodes - sentinel lymph node biopsy (SLNB). SLNB is readily available for patients with melanoma of the torso and limbs, but not everywhere offers SLNB for head and neck melanoma, for a variety of reasons. However, this may result in some patients not having access to new, systemic treatments that prolong life.

The aim of this study is to examine how practice varies nationally, looking at who is offered SLNB after melanoma of the head or neck, what treatments they go on to have, and whether they recover from their melanoma or not with the aim of identifying whether SLNB should be made available to everyone in this group.

The following is a summary of the aims of the research project provided by HUTH:

• Overall aim: To evaluate the burden of disease of head and neck melanoma in the last 5 years, including additional treatments and access to SLNB.

• Primary outcomes:

- What proportion of patients diagnosed with cutaneous melanoma of the head and neck go on to have SLNB?

- How does this compare to the proportion of patients with cutaneous melanoma in other parts of the body that go on to have SLNB?

• Secondary outcomes

- What is the tumour stage of patients with cutaneous melanoma of the head and neck who have SLNB compared to those who do not?

- Do a higher proportion of patients with cutaneous melanoma of the head and neck who have had an SLNB have systemic anti-cancer therapies (or other treatments) for comparable T stage?

- Is there a variation in provision of SLNB for cutaneous melanoma of the head and neck across England?

The project is now complete. HUTH would like to retain this Data to ensure reconstruction of the study analysis is possible if required.

No additional data will be requested from NHS England.

This Data Sharing Agreement (DSA) permits processing of the Data for the purpose of secure storage and back up on the NHS England Secure Data Environment (SDE).

This DSA does not permit any further processing that involves analysis or linkage. Licences for HUTH to access the Data in the SDE have been suspended. Access to the Data will be re-established only for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.

Following publication of the study findings, or submission of the study for publication, it is possible that the findings will be questioned or challenged by third parties through direct contact with HUTH, contact via the publishing journal or an open letter. In such circumstances, HUTH may repeat the previously analyses undertaken to verify that the published results were accurate and may write a response to be issued directly to the challenger or published.

This DSA does not permit any onward sharing of the Data.

If any further data processing is required in addition to the above purposes HUTH must submit an Amendment request to NHS England before Data is accessed.

Data from the following NHS England Data will be retained: NDRS Cancer Consolidated Data Set

The level of the Data being retained is Pseudonymised.

The data is minimised as follows:

Limited to data for a study cohort identified by NHS England as meeting the following criteria:

• Patients diagnosed with conditions relevant to the study identified by specific ICD10 diagnosis code ‘C43’,

• Limited to data between 2016 and 2022.

• Patients ages 18 or over.

HUTH is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

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.

The lawful basis for processing special category data under the UK GDPR is:

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 protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The work has been funded by the British Association of Plastic and Reconstructive Surgeons (BAPRAS) (2271PT). No extension is required as the project is complete. Funding remains in the budget to cover the cost of data archiving.

The funders will have no ability to suppress or otherwise limit the publication of findings.

NHS England (NHSE) is a processor acting under the instructions of HUTH. NHSE’s role is limited to hosting the data in the NHSE Secure Data Environment.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

The relevant records from the NDRS Cancer Consolidated Data Set are held in NHS England’s Secure Data Environment. The Data contain no direct identifying data items. The Data is pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

This DSA permits processing of the Data by NHS England for the purpose of secure storage and back up.

This DSA does not permit any further processing that involves analysis or linkage. Licences for HUTH to access the Data in the SDE have been withdrawn. Access to the Data will only be re-established for the purpose of verifying findings in line with the original objectives of the study by repeating previous analyses described in this DSA.

This DSA does not permit any onward sharing of the Data with the exception that the Data may be viewed for the purpose of an audit by a regulator such as the Medicines and Healthcare products Regulatory Agency (MHRA).

The Data will be stored on NHS England’s Secure Data Environment.

In the event that the Data needs to be accessed for the purposes of audit or to enable verification of previous findings; upon approval by NHS England, licenses to access the Data in the SDE will be re-established for HUTH with authorisation from the Chief Investigator where it can be accessed by HUTH analysts or statisticians, only for the purposes of verifying results of previous analyses by rerunning analyses that were previously undertaken. Data would be accessible only for the minimum period required to enable verification of the analyses and to write a response as appropriate. Responses will adhere to the rules for small number suppression in the HES Analysis Guide.

The data may not be transferred to any other location and may only be accessed by substantive employees of HUTH] for the purposes described above.

This DSA is required for the following reason:

The raw datasets (and any associated datasets and syntax files) may need to be accessed for the purpose of audit. An audit may be required during the period of this DSA. This would involve a systematic and independent review of trial-related activities and documents, to determine whether data were recorded, analysed and accurately reported. Without all the raw datasets this cannot be done.

The expected outputs of the processing will be:

• Annual reports of findings to the funder (BAPRAS).

• Submissions to open access peer reviewed journals.

• Presentations at appropriate national/international conferences.

• Reports to public bodies/stakeholders focussed on melanoma, or skin cancer as a whole.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals (such as British Journal of Dermatology, JAMA Dermatology)

• Conferences (such as BAPRAS annual conference, British Association of Dermatologists annual conference, the Society for Melanoma Research conference)

• Reports aimed at public bodies/stakeholders (such as Melanoma UK [Charity], Melanoma Focus [Charity], The Skin Cancer Foundation [Charity], NICE [Guideline producer], SIGN [Guideline Producer], British Association of Dermatologists [Professional Body], BAPRAS [Professional Body])

The study submitted results for publication in peer reviewed journals in Q4 2025 . The Journals have submitted data queries as part of the peer review process, which the study is responding to. Once accepted, reports will be prepared for the organisations outlined above.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

• Help the system to better understand the health and care needs of populations.

• Lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• Advance understanding of regional and national trends in health and social care needs.

• Inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• Inform decisions on how to effectively allocate and evaluate funding according to health needs.

• Provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

• Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

If outcomes demonstrate a geographical discrepancy in the provision of staging surgery for this common cancer, then the study will be in a strong position to advocate for clearer guidelines on the matter. At present, national guidelines allow for local variation in head and neck SLNB due to concern over greater operative difficulty and greater variability in lymphatic spread in this area. If the study is able to show through it's dataset that outcomes are improved for those who undergo SLNB, then it can advocated for wider access to this procedure for patients. This will be beneficial in both the provisioning of healthcare and is in the public interest (as the public stands to gain from wider access and improved outcomes).

The dissemination plan has been designed to maximise exposure for our results. By disseminating to melanoma-specific charities, as well as the scientific community, our results may be leveraged by charitable stakeholders as well as clinicians in the production of new/updated guidelines.

Displaying or disproving a benefit from access to SLNB, or showing geographical variance, stands to benefit large numbers of patients. Over 2,500 new cases of melanoma of the head and neck are diagnosed every year and though not all of these would be suitable for SLNB, hundreds of patients may be eligible for this staging procedure. Adequate staging may qualify them for further treatment and in turn confer a survival benefit. Furthermore, strong evidence for a geographical variance can be used to standardise procedures available to patients on the NHS (through training or service development in individual NHS trusts). In order to measure any benefit from the outcomes of this work, further prospective research may be needed.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The data so far has identified that:

• Patients have differential access to important staging operations dependent on where they live. This in turn is impacted by the deprivation of the area that they live in.

• Patients have worse outcomes if they live in an area with high deprivation and are diagnosed with malignant melanoma.

We are in the process of publishing these results, which will be used to push for service reconfiguration.