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Analysis of Circulating Exosomes in Melanoma Patients

Analysis of Circulating Exosomes in Melanoma Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05744076
Acronym
EXOMEL1
Enrollment
150
Registered
2023-02-24
Start date
2019-03-01
Completion date
2024-03-31
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

Interventions

None listed

Sponsors

Centre Georges Francois Leclerc
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Quantification of circulating exosomesDay 1Dosage 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

MeasureTime frameDescription
PDL1 markingDay 1Compare 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
Other proteins detectionDay 1Identify 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.
Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.Day 1Dosage 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026