[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606529":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":31,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":10,"enrollmentInfo":44,"targetDuration":10,"studyType":47,"phases":10,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biopsy-proven severe alcoholic hepatitis and control liver specimens",null,"Cases: Adults treated at CHRU de Nancy (2013-2023) for Severe Alcoholic Hepatitis, with archived liver biopsies.\n\nControls: Adults with liver malignancies and archived biopsies.",[13],"Diagnostic Test: TREM-1 expression (via immunohistochemistry) between SAH patients and controls",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","TREM-1 expression (via immunohistochemistry) between SAH patients and controls","this is the first study to focus on hepatocyte-specific TREM-1 expression in human liver tissue\n\nWhat Distinguishes This Study Tissue-Level Focus: Unlike most studies that assess blood biomarkers or systemic inflammation, this research directly measures TREM-1 expression in liver tissue (hepatocytes), offering localized insights into disease severity and immune response.\n\nRetrospective Biobank Utilization: Leverages a rich biobank of archival biopsies spanning 10 years, ensuring real-world data and long-term clinical follow-up-rarely combined at this scale in similar research.\n\nDual Purpose (Diagnostic \\& Prognostic): Most biomarkers are evaluated for either diagnostic or prognostic value-this study uniquely addresses both in a single, comprehensive framework.\n\nTherapeutic Translation Potential: TREM-1 is already a target for pharmacological inhibition (e.g., with peptide inhibitors tested safely in humans for other conditions). This positions the study for rapid clinical translation,",[9],[21],{"name":22,"affiliation":23,"role":24},"Vincent Haghnejad, MD","CHRU de Nancy","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Vincent HAGHNEJAD, MD","CONTACT","+33383153354","v.haghnejad@chru-nancy.fr",{"type":24,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"HAGHNEJAD Vincent","Dr","100606529","livertrem-1-hepatic-trem-1-expression-and-prognosis-in-severe-alcoholic-hepatitis-100606529",false,"NCT07176741","LiverTREM-1: Hepatic TREM-1 Expression and Prognosis in Severe Alcoholic Hepatitis","Measurement of Hepatocyte TREM-1 Expression Level to Evaluate Its Intrinsic Performance and Prognostic Value in Severe Symptomatic Alcohol-related Hepatitis","Liver TREM-1","Inclusion Criteria:\n\nCases:\n\n* Individuals who received full information about the study and did not object to the use of their data within this research.\n* 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.\n* Archived liver biopsy slides available at CHRU de Nancy.\n* Adult patients at the time of diagnosis.\n\nControls:\n\n* Individuals who received full information about the study and did not object to the use of their data within this research.\n* Patients treated and operated on at CHRU de Nancy for hepatocellular carcinoma, colorectal cancer liver metastasis, or cholangiocarcinoma between January 1, 2013, and December 31, 2023.\n* Archived liver biopsy slides available at CHRU de Nancy.\n* Adult patients at the time of diagnosis.\n\nExclusion Criteria:\n\n• None","ALL","18 Years",{"count":45,"type":46},300,"ESTIMATED","OBSERVATIONAL","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.\n\nTREM-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.\n\nObjectives\n\nPrimary Objective:\n\nCompare TREM-1 expression (via immunohistochemistry) between SAH patients and controls with other liver diseases (e.g., HCC, metastatic colon cancer, cholangiocarcinoma).\n\nSecondary Objectives:\n\nDetermine optimal antibody dilution for TREM-1 staining.\n\nAssess diagnostic performance (sensitivity, specificity, PPV, NPV).\n\nIdentify homogeneous SAH subgroups using clinical, histological, and biological data.\n\nEvaluate prognostic value of TREM-1 expression for:\n\n2-month mortality\n\nCorticosteroid response (bilirubin regression at Day 7)\n\nLille score \\\u003C0.45 at Day 7\n\nCompare TREM-1's predictive power to standard scores (MELD, Maddrey, Lille, etc.).\n\nMethodology\n\nPopulation:\n\nCases: Adults treated at CHRU de Nancy (2013-2023) for SAH, with archived liver biopsies.\n\nControls: Adults with liver malignancies and archived biopsies.\n\nSample Size:\n\nPhase I: 12 cases, 6 controls\n\nPhase II: 150 cases, 150 controls\n\nData Sources: Medical records, archived pathology slides\n\nStatistical Tools: Logistic regression, survival analysis, ROC curves, clustering, SAS\u002FR software\n\nExpected Outcomes \\& Impact Improved prognostic stratification and therapeutic guidance for SAH patients\n\nBetter targeting of corticosteroid therapy to reduce unnecessary risk\n\nEarly referral for liver transplantation when appropriate\n\nValidation of TREM-1 as a diagnostic\u002Fprognostic biomarker\n\nFoundation for future TREM-1-targeted clinical trials\n\nPotential paradigm shift linking liver histology with real-time clinical decision-making\n\nEnhanced resource allocation and patient management",[50],"Severe Alcoholic Hepatitis",[52,53,54,55,56,57,58,59],"TREM-1","sAH","biomarker","prognosis","alcoholic hepatitis","alcohol use disorder","AUD","cirrhosis","NOT_YET_RECRUITING","2025-09-09",{"date":63,"type":64},"2025-09-16","ACTUAL",{"date":66,"type":46},"2025-10-01",{"date":68,"type":46},"2026-12",{"name":5,"class":6}]