Markers of relapse in melanoma
Research type
Research Study
Full title
Markers of relapse in melanoma
IRAS ID
167721
Contact name
Shobha Silva
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Sheffield Teaching Hospital Research Department, STH18695
Duration of Study in the UK
20 years, 9 months, 0 days
Research summary
Melanoma is the most serious form of skin cancer. The 5-year survival (for melanomas measuring more than 3.5mm thick) is only 50%, due to the high relapse rate. Following metastatic relapse, average prognosis is around 6-9 months. With conventional chemotherapy options, response rates are low; while with newer targeted agents, response rates are higher and outlook is better, but only in a proportion of patients. An on-going issue is how best to monitor patients. Once clinical symptoms of relapse have manifested, often it is too late for available therapies to be of significant benefit. Therefore, it would be immensely beneficial if reliable markers of relapse or progression can be developed, to enable early initiation of treatment. Plasma circulating cell-free DNA (ccfDNA) provides an easily accessible source of tumour-derived DNA which has potential for the development of markers of relapse. An increase in the amount of tumour-derived DNA has been correlated with tumour burden and relapse. Also, somatic genetic mutations (eg BRAF in melanoma), can be identified in ccfDNA. However, the clinical utility of ccfDNA has not been proven, partly due to the lack of longitudinal data from both melanoma patients and healthy controls. This study aims to address this by performing a longitudinal-study monitoring ccfDNA levels in melanoma patients and health controls. Patients with a diagnosis of melanoma would be eligible, and asked to complete a questionnaire(once only) and provide a blood sample 3-monthly for upto 5 years at their routine hospital appointments. Concurrently, their partners/family(as healthy controls) would be asked to provide the same. The recent feasibility study (GEMS) confirmed that patients and healthy controls can be recruited, and that ccfDNA can be extracted from blood samples obtained. The study showed a statistically significant difference in the level of ccfDNA in patients with active disease compared to those without.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1275
Date of REC Opinion
11 Dec 2014
REC opinion
Favourable Opinion