RecruitingNCT06470997

Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint Inhibitors

Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint

Sponsor

University Hospital, Montpellier

Enrollment

60 participants

Start Date

Jul 17, 2024

Study Type

OBSERVATIONAL

Summary

Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.

Eligibility

Min Age: 18 Years

Inclusion Criteria25

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
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
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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Interventions

BIOLOGICALBlood sample collection

6 collections of 5mL blood samples as part of usual care (pre-inclusion visit at Day-7, inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months) and 5 blood sample collections of 5 mL for proteomic analysis in the context of research (inclusion visit at Day 0, visit1 at Day 14, visit2 at Day 28, visit3 at Day 90, visit4 at 6 months)

PROCEDURELiver biopsy

1 liver biopsy performed as part of routine care and 1 additional sample for research: transparietal needle biopsy under ultrasound identification under local anesthesia by a radiologist, 1 to 2 cm per core taken, 2 cores are taken.

Locations(1)

CHU de Montpellier

Montpellier, France, France

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NCT06470997