Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors

RecruitingOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

July 17, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

June 1, 2026

Conditions
Immune-mediated Hepatitis
Interventions
BIOLOGICAL

Blood sample collection

6 collections of 5mL blood samples as part of usual care (pre-inclusion visit at Day-7, inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months) and 5 blood sample collections of 5 mL for proteomic analysis in the context of research (inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months)

PROCEDURE

Liver biopsy

1 liver biopsy performed as part of routine care and 1 additional sample for research: transparietal needle biopsy under ultrasound identification under local anesthesia by a radiologist, 1 to 2 cm per core taken, 2 cores are taken.

Trial Locations (1)

34295

RECRUITING

CHU de Montpellier, Montpellier

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER