Blood test could spot Immunotherapy-Linked liver damage
NCT ID NCT06470997
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to identify specific blood markers that can distinguish hepatitis caused by immune checkpoint inhibitors from other types of autoimmune hepatitis. Researchers will collect blood samples and liver tissue from 60 adults receiving immunotherapy. The goal is to improve diagnosis and treatment of this side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors quickly identify and treat hepatitis caused by immunotherapy, avoiding unnecessary treatments.
- What could go wrong
- This is a small, early-stage study focused on finding markers, not testing a treatment. The markers may not prove reliable in larger, more diverse groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
CHILI group: patients with hepatitis induced by immune checkpoint inhibitors Control group: patients with idiopathic autoimmune hepatitis
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Montpellier
RECRUITINGMontpellier, France, 34295, France
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