NCT06710093Not yet recruiting
Power of Liquid Biopsy Tracking in Immunotherapy Treated Stage IV Melanoma
Source: ClinicalTrials.gov · Last updated 29 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT06710093
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Feb 2025 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to comply with schedule of study samples to be collected. Concurrent active malignancies needing treatment
Other illness
- Unable to provide informed consent due to psychological, medical or cognitive conditions.
Other
- Not on routine surveillance with interval imaging per standard of care
Who the study is looking for
- 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
- Age over 16
- Not previously diagnosed with HIV, Hepatitis B or C (does not need testing)
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Marsden Coordinator of this site? Confirm its status | Chelsea | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.