Clinical trial · Observational
Analysis of Circulating Exosomes in Melanoma Patients
NCT05744076CI-TRIAL-00064220EXOMEL1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quantification of circulating exosomes
- timeFrame
- Day 1
- description
- 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 (3)
- measure
- PDL1 marking
- timeFrame
- Day 1
- description
- 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
- measure
- Other proteins detection
- timeFrame
- Day 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNardin 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 40552104