NCT01065233

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2013

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

February 8, 2010

Last Update Submit

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)

Genetic: DNA extraction

alcoholic cirrhosis without viral infection

patient with alcoholic cirrhosis without viral infection

Genetic: DNA extraction

Interventions

DNA extraction of blood sample for DNAship analysis

alcoholic cirrhosis with viral infectionalcoholic cirrhosis without viral infection

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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

Location

Jean Verdier UH

Paris, 75000, France

Location

Paul Brousse UH

Paris, 75000, France

Location

Rennes UH

Rennes, 35000, France

Location

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.

Biospecimen

Retention: SAMPLES WITH DNA

2 blood samples of 5ml for DNA extraction

MeSH Terms

Conditions

Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Liver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

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

Locations