CDCHC: Pangenomic Study During Alcoholic Cirrhosis

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01065233
• Collaborator: (none)
• Enrollment: 1,325
• Locations: 4
• Actual Duration (Months): 56.9
• Patients Per Site: 331.3
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Alcoholic Cirrhosis	Genetic: DNA extraction

Study Design

• Study Type: Observational
• Actual Enrollment: 1325 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis
• Actual Study Start Date: Oct 23, 2008
• Actual Primary Completion Date: Dec 27, 2011
• Actual Study Completion Date: Jul 20, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Existence of HCC and Pangenomic analysis of DNA polymorphism []

   Existence of HCC and determination of which genetic polymorphism are predisposing to HCC or preventing for HCC

Secondary Outcome Measures

1. cirrhosis severity (compensated or not) []

   Analysis of the genetic polymorphism involved in the severity of cirrhosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nantes UH	Nantes		France	44000
2	Jean Verdier UH	Paris		France	75000
3	Paul Brousse UH	Paris		France	75000
4	Rennes UH	Rennes		France	35000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01065233
• Other Study ID Numbers: BRD/07/08-M
• First Posted: Feb 9, 2010
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Additional relevant MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis

Study Results

No Results Posted as of Sep 17, 2021