Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-05 @ 7:52 PM
Study NCT ID:
NCT04106518
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D008104', 'term': 'Liver Cirrhosis, Alcoholic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 447}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of alcoholic hepatitis in heavy drinkers with jaundice', 'timeFrame': 'At baseline (time of liver biopsy)', 'description': 'Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'at 12 months', 'description': 'Survival rate at 12 months'}, {'measure': 'Change in serum total bilirubin', 'timeFrame': 'Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months', 'description': 'Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum'}, {'measure': 'Change in serum creatinine', 'timeFrame': 'Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months', 'description': 'Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter'}, {'measure': 'Change in MELD (Model for End-stage Liver Disease)score', 'timeFrame': 'Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months', 'description': 'The MELD score is a validated tool based on INR, creatinine and bilirubin measured in the blood with the following formula:(9.57 × log creatinine in milligrams per deciliter) + (3.78 × log bilirubin in milligrams per deciliter) + (11.20 × log international normalized ratio) + 6.43. The MELD score is used in liver disorders to assess the degree of liver failure. It has no unit.'}, {'measure': 'Identification of inflammatory and biochemical profiles of patients with severe, non-severe and cirrhotic alcoholic hepatitis, based on the constitution of a biobank (serum and plasma)', 'timeFrame': 'Baseline, at 7 days, at 30 days and at 12 months', 'description': 'Serum and plasma evaluation of translational markers (e.g. cytokines) associated with inflammation in patients with alcohol-related liver disease. The list of markers which will be assessed cannot be determined at present and will depend on other ongoing studies performed in alcoholic hepatitis.'}, {'measure': 'Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample)', 'timeFrame': 'Baseline', 'description': 'Evaluation of genetic markers associated with alcoholic hepatitis as compared to patients with alcohol-related liver disease without alcoholic hepatitis. We will use a non a priori approach as recommended in genetic studies. Thus, the list of genetic markers cannot be provided at that time.'}, {'measure': 'Measurement of diagnostic performance (area under the ROC curve)', 'timeFrame': 'At baseline', 'description': 'Measurement of diagnostic performance (area under the ROC curve) of the simple and non-invasive clinical and biological criteria for alcoholic hepatitis proposed in an international expert opinion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cohort', 'alcoholic hepatitis', 'alcoholic cirrhosis', 'pathophysiology', 'bio bank', 'pan-genomic study'], 'conditions': ['Alcoholic Liver Disease', 'Severe Alcoholic Hepatitis', 'Alcoholic Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to jaundice will receive a liver biopsy in accordance with the usual management for diagnosis of alcoholic hepatitis, according to the recommendations of the European Association of Liver Diseases (EASL).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor SAH group:\n\n* Alcohol consumption :\n\n * On average\\> 40 g / day for women and 50 g / day for men\n * Duration:\\> 5 years\n* Recent jaundice episode (less than 3 months)\n* Bilirubin\\> 50 mg / l (85μmol / l)\n\nFor NSAH group:\n\n\\- Alcohol consumption :\n\n* On average\\> 40 g / day for women and 50 g / day for men\n* Duration:\\> 5 years\n\nFor cirrhosis (control) group:\n\n* Alcohol consumption :\n\n * On average\\> 40 g / day for women and 50 g / day for men\n * Duration:\\> 5 years\n* Unambiguous presence of cirrhosis criteria, including:\n\n * clinical signs (ascites, stellar angiomas ...) and / or\n * radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or portal hypertension) and / or\n * biological signs (increased INR, thrombocytopenia) and / or\n * endoscopic signs (oesophageal / gastric varices)\n\nExclusion Criteria:\n\nFor NAH and NSAH groups:\n\n* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)\n* Presence of hepatocellular carcinoma\n* HIV infection\n\nFor cirrhosis (control) group:\n\n* History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode\n* Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)\n* Presence of hepatocellular carcinoma\n* HIV infection"}, 'identificationModule': {'nctId': 'NCT04106518', 'acronym': 'COMADHAA', 'briefTitle': 'Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease', 'orgStudyIdInfo': {'id': '2017_51'}, 'secondaryIdInfos': [{'id': '2018-A02286-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'cirrhosis', 'description': 'Patients with alcoholic liver disease without alcoholic hepatitis'}, {'label': 'severe alcoholic hepatitis', 'description': 'Patients with severe alcoholic hepatitis ( Maddrey score ≥32)'}, {'label': 'non-severe alcoholic hepatitis', 'description': 'Patients with non-severe alcoholic hepatitis (Maddrey score \\<32)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chr Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chru Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bondy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Jean Verdier, AH-HP', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Nord - Chu38 - La Tronche', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Association Hopital Saint Joseph - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hu Est Parisien Site St Antoine Aphp - Paris 12', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Alexandre Louvet, MD,PhD', 'role': 'CONTACT', 'email': 'alexandre.louvet@chru-lille.fr', 'phone': '03 20 44 55 97', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandre Louvet, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}