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Pangenomic Study During Alcoholic Cirrhosis (CDCHC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01065233
First received: February 8, 2010
Last updated: August 12, 2011
Last verified: April 2010
History of Changes
  Purpose

Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.


Condition Intervention
Alcoholic Cirrhosis
 Genetic: DNA extraction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Existence of HCC and Pangenomic analysis of DNA polymorphism [ Designated as safety issue: No ]
    Existence of HCC and determination of which genetic polymorphism are predisposing to HCC or preventing for HCC


Secondary Outcome Measures:
  • cirrhosis severity (compensated or not) [ Designated as safety issue: No ]
    Analysis of the genetic polymorphism involved in the severity of cirrhosis


Biospecimen Retention:   Samples With DNA

2 blood samples of 5ml for DNA extraction


Estimated Enrollment: 600
Study Start Date: May 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
alcoholic cirrhosis with viral infection
patient with alcoholic cirrhosis with viral infection (300 patients)
 Genetic: DNA extraction
DNA extraction of blood sample for DNAship analysis
alcoholic cirrhosis without viral infection
patient with alcoholic cirrhosis without viral infection
 Genetic: DNA extraction
DNA extraction of blood sample for DNAship analysis

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

2 groups with 2 subgroups:

  • patient with HCC
  • HCC with Child A
  • HCC with Child B/C
  • patient without HCC
  • Child A without HCC
  • Child B/C without HCC
Criteria

Inclusion Criteria:

  • 35 to 70 years old
  • Compensated cirrhosis or not
  • Caucasian origin of the parents
  • Patient with cirrhosis (histological proof or obvious)

Exclusion Criteria:

  • HIV, HBV, HCV positive
  • Known Homozygotia (C282Y+/+)
  • Important hepatocytary iron overload for patient with resection
  • HCC non histologically prooved
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065233

Contacts
Contact: Cyrille Feray, MD 0240087529 cyrille.feray@chu-nantes.fr

Locations
France
Nantes UH Recruiting
Nantes, France, 44000
Contact: Cyrille Feray, MD     0240087529     cyrille.feray@chu-nantes.fr    
Principal Investigator: Cyrille Feray, MD            
Jean Verdier UH Recruiting
Paris, France, 75000
Contact: Jean-Claude Trichet, MD     01 48 02 62 80     jean-claude.trinchet@jvr.aphp.fr    
Principal Investigator: Jean-Claude Trinchet, MD            
Paul Brousse UH Recruiting
Paris, France, 75000
Contact: Didier Samuel, MD     0145593199     Didier.samuel@pbr.aphp.fr    
Principal Investigator: Didier Samuel, MD            
Rennes UH Recruiting
Rennes, France, 35000
Contact: Michel Messner, MD     02 99 28 42 97     michel.messner@chu-rennes.fr    
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Anne Omnes, CPRC - NantesUH
ClinicalTrials.gov Identifier: NCT01065233     History of Changes
Other Study ID Numbers: 07/8-M
Study First Received: February 8, 2010
Last Updated: August 12, 2011
Health Authority: France: French Data Protection Authority

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
 Substance-Related Disorders
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 19, 2013