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

NCT06470997 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-11-21

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Lucy MEUNIER, MD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2027-01-18
Completion
2027-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470997 on ClinicalTrials.gov