Identifying blood biomarkers for hepatitis caused by immune checkpoint inhibitors
Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint
This study is trying to find specific blood markers in patients who have liver problems caused by immune checkpoint inhibitors to see how they differ from those with regular autoimmune hepatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, France) |
| Trial ID | NCT06470997 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify specific blood biomarkers associated with immune-mediated hepatitis induced by immune checkpoint inhibitors (ICIs) and compare them to those found in idiopathic autoimmune hepatitis. The study will involve collecting blood samples and performing liver biopsies on patients who have experienced severe hepatitis due to ICIs. The investigators hypothesize that there are distinct mechanistic differences between liver injuries caused by ICIs and those from autoimmune liver diseases, which will be explored through proteomic analysis. The findings could enhance understanding of the underlying mechanisms and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have experienced grade 3 or 4 hepatitis due to immune checkpoint inhibitors.
Not a fit: Patients who have not been treated with immune checkpoint inhibitors or who have mild hepatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic and prognostic tools for patients suffering from hepatitis induced by immune checkpoint inhibitors.
How similar studies have performed: While there have been studies comparing histological damage in similar contexts, this specific approach using proteomic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for patients in the CHILI group: * Patient \> 18 years old * Patient treated with immune checkpoint inhibitors (ICI) alone or in combination * Patient suffering from Hepatitis secondary to immune checkpoint inhibitors (ICI) grade 3 or 4 Common Terminology Criteria For Adverse Events (CTCAE)\* * Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not started, or started less than 30 days ago * Grade 3 or 4 hepatitis: increase in transaminases and/or alkaline phosphatases ≥ 5 x Upper Limit of Normal (ULN) or total bilirubin ≥ 3 Inclusion criteria for patients in the control group: * Patient \> 18 years old * Patient suffering from Primary Biliary Cholangitis (PBC)\* or Autoimmune Hepatitis (AIH)\*\* or Primary Sclerosing Cholangitis (PSC) \*\*\* Primary Biliary Cholangitis (PBC)\* diagnosis : Association of at least 2 of the following 3 criteria : * Cholestasis (PAL \> 1.5N, Gamma GT \> 3N) chronic (\> 6 months) without ultrasound abnormality of the bile ducts. * M2 type anti-mitochondria Ab \> 1/40th * Characteristic histological lesions (non-suppurative destructive cholangitis) or compatible (portal inflammation, granulomas, ductular proliferation, ductopenia, cholestasis). \*\* AIH diagnosis : ALT \> 5 N / Ig G \> 1.5 - 2 N or anti-smooth muscle ≥ 1/80 / Interface hepatitis of marked intensity The Hepactic Activity Index (HAI) score makes it possible to confirm the diagnosis when all the diagnostic criteria are not met. \*\*\* PSC diagnosis: presence of chronic cholestasis (alkaline phosphatase \> 1.5 N or GGT \> 3 N) and typical abnormalities of the bile ducts on cholangio-MRI (Magnetic Resonance Imaging), and in the absence of cause of secondary sclerosing cholangitis * Treatment with corticosteroids or Ursodeoxycholic acid (UDCA) not initiated, or started less than 30 days ago Non-inclusion criteria: * Impossibility of following the patient during the study period * Liver biopsy not possible * Other hepatitis diagnoses * Failure to obtain consent * Unemancipated minors, people unable to express their consent * Non-affiliation to a social security or equivalent scheme, * Persons placed under judicial protection, * Person participating in another research including a period of exclusion still in progress. * Pregnant or breastfeeding women * De novo or old diagnosis (at the time of a flare-up)
Where this trial is running
Montpellier, France
- CHU de Montpellier — Montpellier, France, France (Recruiting)
Study contacts
- Study coordinator: Lucy MEUNIER, MD
- Email: lucy-meunier@chu-montpellier.fr
- Phone: 0467330224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.