Alcoholic CirrhosisCDCHCNCT01065233
Pangenomic Study During Alcoholic Cirrhosis
An observational study of Alcoholic Cirrhosis, run by Nantes University Hospital at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- DNA extraction
- How many people
- 1,325 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Oct 2008to 20 Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 35 to 70 years old
- Compensated cirrhosis or not
- Caucasian origin of the parents
- Patient with cirrhosis (histological proof or obvious)
Who cannot join
- HIV, HBV, HCV positive
- Known Homozygotia (C282Y+/+)
- Important hepatocytary iron overload for patient with resection
- HCC non histologically prooved
Trial locations and contacts
4 sites in 1 country.
France4 sites
Nantes UH
Nantes, 44000
Jean Verdier UH
Paris, 75000
Paul Brousse UH
Paris, 75000
Rennes UH
Rennes, 35000
About this study
Official title: 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.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- DNA extraction
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extractionGenetic
DNA extraction of blood sample for DNAship analysis
| Study group | Role | What they receive |
|---|---|---|
| alcoholic cirrhosis with viral infection | patient with alcoholic cirrhosis with viral infection (300 patients) Receives: Genetic: DNA extraction | |
| alcoholic cirrhosis without viral infection | patient with alcoholic cirrhosis without viral infection Receives: Genetic: DNA extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Analysis of the genetic polymorphism involved in the severity of cirrhosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study start23 Oct 2008
- Primary completion27 Dec 2011
- Study completion20 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065233
- Sponsor's protocol ID
- BRD/07/08-M
- Acronym
- CDCHC
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2010
- Last updated
- 17 Sep 2021
- Results posted
- No
Publications
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.
PubMed 25522809
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis
- ClinicalTrials.gov ID
- NCT01065233
- Acronym / sponsor ID
- CDCHC / BRD/07/08-M
- Conditions
- Alcoholic Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Oct 2008 (actual)
- Primary completion
- 27 Dec 2011 (actual)
- Study completion
- 20 Jul 2013 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcoholic cirrhosis with viral infection | – | Genetic: DNA extractionpatient with alcoholic cirrhosis with viral infection (300 patients) |
| alcoholic cirrhosis without viral infection | – | Genetic: DNA extractionpatient with alcoholic cirrhosis without viral infection |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 35 to 70 years old
- Compensated cirrhosis or not
- Caucasian origin of the parents
- Patient with cirrhosis (histological proof or obvious)
Key exclusion criteria (4 listed)
- HIV, HBV, HCV positive
- Known Homozygotia (C282Y+/+)
- Important hepatocytary iron overload for patient with resection
- HCC non histologically prooved
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA extractionDNA extraction of blood sample for DNAship analysis | Genetic | alcoholic cirrhosis with viral infection, alcoholic cirrhosis without viral infection |
Primary outcome
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
1 secondary outcome
cirrhosis severity (compensated or not)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 25522809Archambeaud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Cirrhosis, run by Nantes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of HCC and Pangenomic analysis of DNA polymorphism. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.