Clinical trial · Observational
National Cohort of Uncomplicated Alcoholic Cirrhosis
CIRRAL: Hepatocellular Carcinoma in Patients With Uncomplicated Alcoholic Cirrhosis: Incidence and Predictive Factors. A Multicentric Prospective Cohort
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcoholic Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- HCC Occurrence
- timeFrame
- 3 years
- description
- cumulative incidence within 3 years
Secondary outcomes (3)
- measure
- Mortality
- timeFrame
- 3 years
- description
- overall mortality - whatever the cause of death
- measure
- Liver-related mortality
- timeFrame
- 3 years
- description
- cumulative incidence of liver-related deaths
- measure
- Alcohol- and cirrhosis-related event free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * histologically proven cirrhosis * no previous HCC (treated or not ) * excessive consumption of alcohol, considered as the main cause of cirrhosis * signed informed consent. Exclusion Criteria: * serious associated short-term life threatening disease (except associated HIV viral infection and the liver disease itself), * decompensation of cirrhosis (bleeding or ascites), * co-infection with HBV or HCV; * liver focal lesion suggestive of HCC * Child Pugh score ≥ 7 (Class B or C). * patient under guardianship * pregnant women * inability to regular monitoring, for whatever reason
References
Publications (2)
- DERIVEDLouvet A, Bourcier V, Archambeaud I, d'Alteroche L, Chaffaut C, Oberti F, Moreno C, Roulot D, Dao T, Moirand R, Duclos-Vallee JC, Goria O, Nguyen-Khac E, Pol S, Carbonell N, Gournay J, Elkrief L, Fouchard-Hubert I, Chevret S, Ganne-Carrie N; CIRRAL group. Low alcohol consumption influences outcomes in individuals with alcohol-related compensated cirrhosis in a French multicenter cohort. J Hepatol. 2023 Mar;78(3):501-512. doi: 10.1016/j.jhep.2022.11.013. Epub 2022 Nov 22. PMID 36423805
- DERIVEDGanne-Carrie N, Nahon P, Chaffaut C, N'Kontchou G, Layese R, Audureau E, Chevret S; CIRRAL group; ANRS CO12 CirVir group. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance. JHEP Rep. 2021 Mar 26;3(3):100285. doi: 10.1016/j.jhepr.2021.100285. eCollection 2021 Jun. PMID 34522876