Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470997
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-07
Brief Title:
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pro-CHILI
Brief Summary:
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis
Detailed Description:
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 07 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None