Analysis of Circulating Exosomes in Melanoma Patients

Active, not recruiting

• Conditions: Melanoma

• Registration Number: NCT05744076
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantification of circulating exosomes	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 Outcome Measures

Name	Time	Method
Other proteins detection	Day 1	Identify other proteins of interest in circulating exosomes. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation.
PDL1 marking	Day 1	Compare PD-L1 labeling in exosomes to PD-L1 labeling in plasma and in tumor tissue. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation
Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.	Day 1	Dosage of PD-L1 in circulating exosomes. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France