NCT01213927

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
709

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

8.1 years

First QC Date

October 1, 2010

Last Update Submit

February 18, 2019

Conditions

Alcoholic Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • HCC Occurrence

    cumulative incidence within 3 years

    3 years

Secondary Outcomes (3)

  • Mortality

    3 years

  • Liver-related mortality

    3 years

  • Alcohol- and cirrhosis-related event free survival

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

French primary care hospitals

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Verdier hospital (AP-HP)

Bondy, 93140, France

Location

Related Publications (2)

  • Louvet 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: 36423805DERIVED

  • Ganne-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: 34522876DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

At enrollement, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Nathalie GANNE, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2018

Study Completion

October 1, 2021

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

FR(1)