An observational study in Hepatocellular Carcinoma, sponsored by University Hospital, Bordeaux. Completed at 14 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by University Hospital, Bordeaux · Observational
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).
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. Nevertheless, 10 to 40% of HCCs can develop on non-cirrhotic terrain and about 5% on nonfibrotic liver (NfHCC). In 20 to 40% of these NfHCCs, no classical HCC risk factor is identified. Some cases could be the result of a transformation of an adenoma. Others may be associated with yet non-formally identified toxins and / or a specific genetic predisposition. While there is a lot of data on alterations of signaling pathways (ß-catenin, AKT / mTOR, Ras / pERK, etc.) in "classical" HCCs, altered pathways remain unknown in most NfHCCs, even in some cases, activation of β-catenin, inactivating mutations of HNF1 or activators of gp130 have been shown. A specific study of NfHCCs, rather rare cancers, represents an opportunity to look for directly carcinogenic factors in the absence of cirrhosis, and to dissect the involved carcinogenesis pathways.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 283 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CASES: patients 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)
Exclusion Criteria:
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
Other: Blood test and self-administrated questionnaires
exposure to Viral hepatitis B
binary yes / undiagnosed by positive serology for anti-HBc antibodies isolated or associated with positive serology for anti-HBs antibodies
Time frame: Baseline
exposure to viral hepatitis C
binary yes / undiagnosed by positive serology for positive anti-HCV antibodies
Time frame: baseline
exposure to Alcohol
binary variable, separating large consumers from others
Time frame: baseline
exposure to Exogenous female hormones
oral contraceptive coded as a binary variable
Time frame: baseline
history of liver pathology
binary variable: yes/no
Time frame: baseline
Family history of liver cancer
binary variable: yes/no
Time frame: baseline
Diabetes
categorical variable (depending on the type of diabetes: 1 or 2).
Time frame: baseline
Dyslipidemias
qualitative variables: hypercholesterolemia / hyper triglyceridemia
Time frame: baseline
Medical treatments for dyslipidemia
depending on the type of medication: statins, fibrates, other
Time frame: baseline
Metabolic syndrome
binary variable: present / absent
Time frame: baseline
Age of first menstruation
quantitative variable in years
Time frame: baseline
Parity
number of children
Time frame: baseline
breastfeeding
binary variable : yes / no
Time frame: baseline
Menstrual status
menopausal status will be treated as a binary variable
Time frame: baseline
Duration of exposure to different variables
quantitative variable in months
Time frame: baseline
fruits
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
vegetables
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
meat
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
fish
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
dairy products
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
fats
frequency of intake assessed by a frequency food questionnaire
Time frame: baseline
Plan to share: No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux