Informations générales (source: ClinicalTrials.gov)
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease (COMADHAA)
Observational [Patient Registry]
University Hospital, Lille (Voir sur ClinicalTrials)
octobre 2019
avril 2025
29 juin 2024
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.
Etablissements
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Saint Antoine | Contact (sur clinicalTrials) | ||||
IFSI DE L'HÔPITAL JEAN VERDIER | Contact (sur clinicalTrials) | ||||
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Centre Hospitalier Universitaire - Caen - France | Contact (sur clinicalTrials) | ||||
Hôpital Claude Huriez, CHU - Lille - France | Contact (sur clinicalTrials) | ||||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
Association Hopital Saint Joseph - Marseille - Marseille - France | Contact (sur clinicalTrials) | ||||
Chr Angers - Angers - France | Contact (sur clinicalTrials) | ||||
Chru Besancon - Besançon - France | Contact (sur clinicalTrials) | ||||
Chu Montpellier - Montpellier - France | Contact (sur clinicalTrials) | ||||
Hopital Nord - Chu38 - La Tronche - La Tronche - France | Contact (sur clinicalTrials) |
Critères
Tous
Inclusion Criteria:
For SAH group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
- Recent jaundice episode (less than 3 months)
- Bilirubin> 50 mg / l (85μmol / l)
For NSAH group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
For cirrhosis (control) group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
- Unambiguous presence of cirrhosis criteria, including:
- clinical signs (ascites, stellar angiomas ...) and / or
- radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or
portal hypertension) and / or
- biological signs (increased INR, thrombocytopenia) and / or
- endoscopic signs (oesophageal / gastric varices)
For SAH group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
- Recent jaundice episode (less than 3 months)
- Bilirubin> 50 mg / l (85μmol / l)
For NSAH group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
For cirrhosis (control) group:
- Alcohol consumption :
- On average> 40 g / day for women and 50 g / day for men
- Duration:> 5 years
- Unambiguous presence of cirrhosis criteria, including:
- clinical signs (ascites, stellar angiomas ...) and / or
- radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or
portal hypertension) and / or
- biological signs (increased INR, thrombocytopenia) and / or
- endoscopic signs (oesophageal / gastric varices)
For NAH and NSAH groups:
- Presence of another hepatic pathology: evidenced by blood biology, imaging or
histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
- Presence of hepatocellular carcinoma
- HIV infection
For cirrhosis (control) group:
- History established / suggestive of HAA (Clinical, biological and / or histological
criteria) in particular absence of jaundice episode
- Presence of another hepatic pathology: evidenced by blood biology, imaging or
histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
- Presence of hepatocellular carcinoma
- HIV infection