LiverTREM-1: Hepatic TREM-1 Expression and Prognosis in Severe Alcoholic Hepatitis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

Background \& Rationale Severe alcohol-related hepatitis (SAH) is a serious condition with a 3-month mortality rate of \~30%. Diagnosis and prognosis are complex due to non-specific and insensitive clinical, biological, and histological indicators. Corticosteroids-the only validated treatment-are only effective in 50% of cases and can worsen outcomes in non-responders by promoting infections. Liver transplantation remains a limited option due to organ scarcity and patient eligibility.

TREM-1, a pro-inflammatory receptor, has shown promise in inflammatory liver diseases. Its expression in hepatocytes may serve as a biomarker to better classify patients, guide treatment, and improve outcomes.

Objectives

Primary Objective:

Compare TREM-1 expression (via immunohistochemistry) between SAH patients and controls with other liver diseases (e.g., HCC, metastatic colon cancer, cholangiocarcinoma).

Secondary Objectives:

Determine optimal antibody dilution for TREM-1 staining.

Assess diagnostic performance (sensitivity, specificity, PPV, NPV).

Identify homogeneous SAH subgroups using clinical, histological, and biological data.

Evaluate prognostic value of TREM-1 expression for:

2-month mortality

Corticosteroid response (bilirubin regression at Day 7)

Lille score \<0.45 at Day 7

Compare TREM-1's predictive power to standard scores (MELD, Maddrey, Lille, etc.).

Methodology

Population:

Cases: Adults treated at CHRU de Nancy (2013-2023) for SAH, with archived liver biopsies.

Controls: Adults with liver malignancies and archived biopsies.

Sample Size:

Phase I: 12 cases, 6 controls

Phase II: 150 cases, 150 controls

Data Sources: Medical records, archived pathology slides

Statistical Tools: Logistic regression, survival analysis, ROC curves, clustering, SAS/R software

Expected Outcomes \& Impact Improved prognostic stratification and therapeutic guidance for SAH patients

Better targeting of corticosteroid therapy to reduce unnecessary risk

Early referral for liver transplantation when appropriate

Validation of TREM-1 as a diagnostic/prognostic biomarker

Foundation for future TREM-1-targeted clinical trials

Potential paradigm shift linking liver histology with real-time clinical decision-making

Enhanced resource allocation and patient management

Eligibility criteria

Qualifiers

Individuals who received full information about the study and did not object to the use of their data within this research.

Patients managed in one of the intensive care or hepatogastroenterology departments at CHRU de Nancy for severe alcohol-related hepatitis between January 1, 2013, and December 31, 2023.

Archived liver biopsy slides available at CHRU de Nancy.

Adult patients at the time of diagnosis.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • TREM-1 expression (via immunohistochemistry) between SAH patients and controls

Treatment groups

300 Participants
are divided into 1 treatment group

Locations

This trial has no locations