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RECRUITING
NCT06470997

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.

Official title: Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-07-17

Completion Date

2027-01-31

Last Updated

2025-11-21

Healthy Volunteers

No

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.

Locations (1)

CHU de Montpellier

Montpellier, France, France