Status:
COMPLETED
Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study)
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-65 years
Brief Summary
The main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).
Detailed Description
Most hepatocellular carcinoma (HCC) complicates cirrhosis, which is often caused by infection with hepatitis B or C viruses, alcohol, obesity, exposure to aflatoxin B1 (AFB1) or hemochromatosis. Never...
Eligibility Criteria
Inclusion
- CASES: patients aged 18 years and older with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2); signed informed consent; affiliated or beneficiary of a social security system
- CONTROLS: patients aged 18 years and older without NfHCC at baseline; patients for whom an endoscopy is programmed as part of an assessment of intestinal functional disorders, dyspeptic disorders or screening colonoscopy or hospitalized patients in orthopedic surgery / traumatology or rheumatology departments; signed informed consent; affiliated or beneficiary of a social security system
Exclusion
- CASES: HCC diagnosed without pathological examination; hepatic transplantation before the diagnosis of HCC; patients unable to answer questions; patients who do not speak French or live abroad.
- CONTROLS: History of liver cancer; other cancers under treatment except cutaneous cancers; Colonoscopy indicated in case of familial form of colon cancer; patient with cirrhosis; patients unable to answer questions; patients who do not speak French or live abroad; Relationship or same home with the case
Key Trial Info
Start Date :
August 18 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 14 2013
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT03852238
Start Date
August 18 2010
End Date
November 14 2013
Last Update
February 25 2019
Active Locations (14)
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1
CHU Amiens
Amiens, France
2
AP-HP Jean Verdier
Bondy, France
3
CHU Bordeaux
Bordeaux, France
4
CHU Caen
Caen, France