- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065233
Pangenomic Study During Alcoholic Cirrhosis (CDCHC)
Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nantes, France, 44000
- Nantes UH
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Paris, France, 75000
- Jean Verdier UH
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Paris, France, 75000
- Paul Brousse UH
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Rennes, France, 35000
- Rennes UH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
alcoholic cirrhosis with viral infection
patient with alcoholic cirrhosis with viral infection (300 patients)
|
DNA extraction of blood sample for DNAship analysis
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alcoholic cirrhosis without viral infection
patient with alcoholic cirrhosis without viral infection
|
DNA extraction of blood sample for DNAship analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Existence of HCC and Pangenomic analysis of DNA polymorphism
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Existence of HCC and determination of which genetic polymorphism are predisposing to HCC or preventing for HCC
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
cirrhosis severity (compensated or not)
|
Analysis of the genetic polymorphism involved in the severity of cirrhosis
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/07/08-M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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