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Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
Sponsor: University Hospital, Montpellier
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
Conditions
Interventions
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)
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