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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01065233
Other study ID # BRD/07/08-M
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 23, 2008
Est. completion date July 20, 2013

Study information

Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1325
Est. completion date July 20, 2013
Est. primary completion date December 27, 2011
Accepts healthy volunteers No
Gender All
Age group 35 Years to 70 Years
Eligibility 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

Study Design


Intervention

Genetic:
DNA extraction
DNA extraction of blood sample for DNAship analysis

Locations

Country Name City State
France Nantes UH Nantes
France Jean Verdier UH Paris
France Paul Brousse UH Paris
France Rennes UH Rennes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 cirrhosis severity (compensated or not) Analysis of the genetic polymorphism involved in the severity of cirrhosis
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