Analysis of Circulating Exosomes in Melanoma Patients
EXOMEL1
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 14, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFebruary 24, 2023
February 1, 2023
5 years
February 14, 2023
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Quantification of circulating exosomes
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
Day 1
Secondary Outcomes (3)
PDL1 marking
Day 1
Other proteins detection
Day 1
Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.
Day 1
Eligibility Criteria
Melanoma patients admitted in Besançon University Hospital
You may qualify if:
- 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,
You may not qualify if:
- Minor patients
- Patients who have expressed their opposition to the reuse of their data and biological samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Besançon
Besançon, France
Related Publications (1)
Nardin C, Vautrot V, Naiken I, Doussot A, Puzenat E, De Girval C, Garrido C, Aubin F, Gobbo J. Monitoring Pseudoprogression Using Circulating Small Extracellular Vesicles Expressing PD-L1 in a Melanoma Patient Treated With Immune Checkpoint Inhibitors. J Extracell Biol. 2025 Jun 22;4(6):e70066. doi: 10.1002/jex2.70066. eCollection 2025 Jun.
PMID: 40552104DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2023
First Posted
February 24, 2023
Study Start
March 1, 2019
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
February 24, 2023
Record last verified: 2023-02