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Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
Immune checkpoint inhibitors (ICI) have become a pillar of the oncological therapeutic arsenal. Their mechanism of action is based on the restoration of the innate anti-tumor function of T lymphocytes. This mode of action is also the cause of systemic immune-mediated adverse effects. The most common disorders are endocrine, cutaneous and gastrointestinal. The frequency of hepatic toxicities is estimated between 0.7 and 25% depending on the studies, the cancer treated and the ICI combinations used. Currently the description of these hepatitis is brief in the literature and the mechanism of toxicity is not known. Work has already compared histological damage between immune checkpoint inhibitors (CHILI) and autoimmune hepatitis; The investigators find in CHILI a higher ratio of CD8 + /CD4 + lymphocytes. Apart from these clinical, biological or histological descriptions, knowledge is limited. In particular, there are no known predictive factors or prognoses. The investigators hypothesize that there are mechanistic differences between checkpoint inhibitors induced liver injury and idiopathic autoimmune liver disease. Proteomic analysis is a powerful tool for functional analysis.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Montpellier
Montpellier, France, France
Start Date
July 17, 2024
Primary Completion Date
January 18, 2027
Completion Date
January 31, 2027
Last Updated
November 21, 2025
60
ESTIMATED participants
Blood sample collection
BIOLOGICAL
Liver biopsy
PROCEDURE
Lead Sponsor
University Hospital, Montpellier
NCT07167251
NCT05484908
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