Identifying blood biomarkers for hepatitis caused by immune checkpoint inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Montpellier
  Montpellier, France, France Recruiting

Study contacts

• Study coordinator: Lucy MEUNIER, MD
• Email: lucy-meunier@chu-montpellier.fr
• Phone: 0467330224

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.