Analysis of Circulating Exosomes in Melanoma Patients

Melanoma Clinical Trial

— EXOMEL1  

Official title:

Analysis of Circulating Exosomes in Melanoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05744076
• Other study ID #: P/2018/401
• Status: Active, not recruiting
• Start date: March 1, 2019
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PDL1 marking	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	Day 1
Secondary	Other proteins detection	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.	Day 1
Secondary	Determine whether the initial exosome concentration (at T0) is associated with a response to treatment.	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	Day 1