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National Cohort of Uncomplicated Alcoholic Cirrhosis

NCT01213927 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 709

Last updated 2019-02-19

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is increasing in developed countries and is the leading cause of death in patients with cirrhosis. The diagnosis and the early management are key issues that could improve the prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology of underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and Japan, and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved results of anti-viral therapies, this trend should be reinforced with a decreasing proportion of HCC related to viral cirrhosis and an increasing proportion of HCC related to alcoholic cirrhosis. However, natural history of alcoholic cirrhosis remains poorly understood, most studies being retrospective and including a small number of patients. This project is filed by the consortium CIRRAL including French Academic hospitals centers currently involved and referees in the field of alcoholic liver disease and HCC (8 at the moment, and more in the next months). It is a national multicenter prospective study that will include 1200 patients with alcoholic cirrhosis histologically proven over 3 years. The main goal of this cohort is to describe the natural history of a large number of patients with alcoholic cirrhosis prospectively followed, and to identify predictors of the occurrence of HCC.

Conditions

  • Alcoholic Cirrhosis

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • French National Agency for Research on AIDS and Viral Hepatitis

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nathalie GANNE, MD PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2018-11-30
Completion
2021-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213927 on ClinicalTrials.gov