Analysis of Circulating Exosomes in Melanoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Quantification of circulating exosomes
Study Overview
Brief Summary
The hypothesis is that PD-L1[Programmed Death-Ligand 1] labeling in exosomes could be a biomarker of disease progression in melanoma. The rate of circulating exosomes, their size and the exosomal expression of PD-L1 could be correlated with the stage of the disease, the response to treatment and/or the prognosis of patients. In this study, blood samples (EDTA tubes taken as part of routine care at Besançon University Hospital) and associated clinical data are reused.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Melanoma patients admitted in Besançon University Hospital
- •exigible for immunotherapy such as anti PD-L1/PD-1
- •Age ≥18 years
- •Affiliation to a social security system,
Exclusion Criteria
- •Minor patients
- •Patients who have expressed their opposition to the reuse of their data and biological samples
Outcomes
Primary Outcomes
Quantification of circulating exosomes
Time Frame: Day 1
Dosage of proteic biomarkers in circulating exosomes, plasma and tumor tissues. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation
Secondary Outcomes
- Other proteins detection(Day 1)
- PDL1 marking(Day 1)
- Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.(Day 1)