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EXOMEL1: Analysis of Circulating Exosomes in Melanoma Patients

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05744076
Collaborator
Centre Georges Francois Leclerc (Other)
150
Enrollment
1
Location
60
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Analysis of Circulating Exosomes in Melanoma Patients
    Actual Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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.

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Besançon Besançon France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon
    • Centre Georges Francois Leclerc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT05744076
    Other Study ID Numbers:
    • P/2018/401
    First Posted:
    Feb 24, 2023
    Last Update Posted:
    Feb 24, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Feb 24, 2023