Pangenomic Study During Alcoholic Cirrhosis
CDCHC
Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis
1 other identifier
observational
1,325
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2008
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2013
CompletedSeptember 17, 2021
September 1, 2021
3.2 years
February 8, 2010
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (1)
cirrhosis severity (compensated or not)
Study Arms (2)
alcoholic cirrhosis with viral infection
patient with alcoholic cirrhosis with viral infection (300 patients)
alcoholic cirrhosis without viral infection
patient with alcoholic cirrhosis without viral infection
Interventions
DNA extraction of blood sample for DNAship analysis
Eligibility Criteria
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
You may qualify if:
- to 70 years old
- Compensated cirrhosis or not
- Caucasian origin of the parents
- Patient with cirrhosis (histological proof or obvious)
You may not qualify if:
- HIV, HBV, HCV positive
- Known Homozygotia (C282Y+/+)
- Important hepatocytary iron overload for patient with resection
- HCC non histologically prooved
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Nantes UH
Nantes, 44000, France
Jean Verdier UH
Paris, 75000, France
Paul Brousse UH
Paris, 75000, France
Rennes UH
Rennes, 35000, France
Related Publications (1)
Archambeaud I, Auble H, Nahon P, Planche L, Fallot G, Faroux R, Gournay J, Samuel D, Kury S, Feray C. Risk factors for hepatocellular carcinoma in Caucasian patients with non-viral cirrhosis: the importance of prior obesity. Liver Int. 2015 Jul;35(7):1872-6. doi: 10.1111/liv.12767. Epub 2015 Jan 21.
PMID: 25522809DERIVED
Biospecimen
2 blood samples of 5ml for DNA extraction
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 9, 2010
Study Start
October 23, 2008
Primary Completion
December 27, 2011
Study Completion
July 20, 2013
Last Updated
September 17, 2021
Record last verified: 2021-09