SLN Predict: Sentinel Lymph Node Predictor to optimise melanoma care
Clinical Investigators:
Professor Fadi Issa; Associate Professor/Wellcome Trust CRCD Fellow & Consultant Burns & Plastic Surgeon
Mr Oliver Cassell; Consultant Plastic and Reconstructive Surgeon & Honorary Senior Clinical Lecturer University of Oxford
Co-Investigators
Charlotte Proby, Professor of Dermatology
Dr Rubeta Matin, Consultant Dermatologist
Mr Rowan Pritchard Jones, Consultant Plastic Reconstructive Surgeon
Project start date
01/06/2021
Proposed project duration
18months (for the feasibility study, not the prospective trial)
Project Summary
Melanoma patients are treated with wide local excision surgery and sentinel lymph node biopsy (SLNB) as their primary treatment if their melanoma tumour is 0.8mm or thicker. If melanoma cells are found in this first (sentinel) lymph node, patients are offered additional (or adjuvant) drug treatments which can reduce their chances of the melanoma returning.
Less than one in five SLNBs are positive, particularly in thinner melanomas. There are side effects to SLNB which may cause significant lifelong problems for patients, including a swollen leg. It is also important to concentrate the surgical resources for SLNB on those patients that most need it.
American and Dutch researchers have therefore developed a more precise method to select which melanoma patients should have SLNB procedures. The predictor test (SLN Predict) could accurately identify patients with a <5% risk of melanoma cells having spread to a lymph node.
This feasibility study will validate (retrospectively) the SLN Predict test in 1,500 UK melanoma patients for whom the SLNB result is known, which will allow this predictor test to be used in a future larger prospective clinical trial.
There are 2 main aims of the feasibility study
- To validate the predictor test that can identify patients with <5% risk of melanoma cells spreading to a lymph node. If this test is accurate, future patients with <5% risk might not need to have an SLNB, reducing side effects for patients and also saving NHS resources.
- To see if the predictor test can predict the risk of the melanoma recurring after a negative sentinel lymph node biopsy. This will identify high-risk patients with thin (<0.8mm) melanoma that may benefit from having adjuvant drug treatment after their surgery, and who don’t currently receive this as standard.
The funding from Melanoma Focus will allow:
- The retrospective validation of the predictor test (SLN Predict) within an NHS setting
- Feasibility work to support a funding application for a prospective multi-centre clinical trial
Comment from Clinical Investigators
“The funding from melanoma focus has helped kick start this study, which will aim to reduce the need for surgery. It has helped with database management for the sentinel node results and for collecting pathology tissue for analysis.”
Project update, June 2023
There has been significant progress in the SLN Predict Project driven by a clinical fellow.
After successfully securing ethical approval for the feasibility study, the study logistics were planned which involved selecting a ‘real world sample’ patient cohort and a process for acquiring samples from a research biobank in Wales.
In collaboration with the NIHR Research Design Service a comprehensive Patient and Public Involvement (PPI) strategy was developed.
The first round of analyses has been completed. This process involved histological verification of tissue samples and tissue sectioning. These were then delivered to partners in the Netherlands to validate the SLN Predict test. A second batch of samples is now being prepared for delivery, which will be dispatched once the current batch data has been assessed to ensure its quality.
Gene expression data is also expected to be received for analysis in July 2023, and a PPI focus group meeting is provisionally scheduled for early 2024.