NCT06710093
Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma
Not Yet Recruiting · Not specified · Royal Marsden NHS Foundation Trust · registry updated 2024-11-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The advent of immune ICI has remarkably improved survival in advanced melanoma patients in the last decade. Long term responders following 2 years of treatment with immunotherapy go on to surveillance with frequent radiological imaging every 3-6 months up to 5-10 years. This not only exposes patients with a relatively low risk of recurrence to significant amounts of ionising radiation, but also increases the burden and cost on already stretched radiology departments. Therefore, this study aims to assess the feasibility and patient experience of using ctDNA with minimally invasive liquid biopsy assays as a biomarker for detecting disease relapse or progression at the point of radiological progression. Data from this pilot study will help to design a future validation study for establishing optimal liquid biopsy for surveillance in advanced melanoma patients.
Inclusion
- Histologically proven melanoma
- Unresectable stage III or stage IV disease, with confirmed radiological disease progression within 1 month of recruitment
- Patient has received at least 1 cycle of immunotherapy with checkpoint inhibitors for melanoma
- Undergoing standard of care active treatment with regular interval imaging or routine imaging surveillance following treatment completion/cessation
- Not previously diagnosed with HIV, Hepatitis B or C (does not need testing)
Exclusion
- Not on routine surveillance with interval imaging per standard of care
- Unable to provide informed consent due to psychological, medical or cognitive conditions.
- Unable to comply with schedule of study samples to be collected. Concurrent active malignancies needing treatment