Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study)

Hepatocellular Carcinoma Clinical Trial

— NoFlic  

Official title:

Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver (NoFlic Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852238
• Other study ID #: CHUBX 2010/03
• Status: Completed
• Start date: August 18, 2010
• Est. completion date: November 14, 2013

Study information

• Verified date: January 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: November 14, 2013
• Est. primary completion date: November 14, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Blood test and self-administrated questionnaires

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	AP-HP Jean Verdier	Bondy
France	CHU Bordeaux	Bordeaux
France	CHU Caen	Caen
France	AP-HP Hopital Antoine Béclère	Clamart
France	AP-HP Hopital Beaujon	Clichy
France	CHI Créteil	Créteil
France	CHU Grenoble	Grenoble
France	Hopital Edouard Herriot	Lyon
France	Hospices Civiles de Lyon	Lyon
France	AP-HP Cochin	Paris
France	AP-HP Hopital Henri Mondor	Paris
France	AP-HP Hopital Saint Antoine	Paris
France	CHU Villejuif	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	exposure to Alcohol	binary variable, separating large consumers from others	baseline
Other	exposure to Exogenous female hormones	oral contraceptive coded as a binary variable	baseline
Other	history of liver pathology	binary variable: yes/no	baseline
Other	Family history of liver cancer	binary variable: yes/no	baseline
Other	Diabetes	categorical variable (depending on the type of diabetes: 1 or 2).	baseline
Other	Dyslipidemias	qualitative variables: hypercholesterolemia / hyper triglyceridemia	baseline
Other	Medical treatments for dyslipidemia	depending on the type of medication: statins, fibrates, other	baseline
Other	Metabolic syndrome	binary variable: present / absent	baseline
Other	Age of first menstruation	quantitative variable in years	baseline
Other	Parity	number of children	baseline
Other	breastfeeding	binary variable : yes / no	baseline
Other	Menstrual status	menopausal status will be treated as a binary variable	baseline
Other	Duration of exposure to different variables	quantitative variable in months	baseline
Other	fruits	frequency of intake assessed by a frequency food questionnaire	baseline
Other	vegetables	frequency of intake assessed by a frequency food questionnaire	baseline
Other	meat	frequency of intake assessed by a frequency food questionnaire	baseline
Other	fish	frequency of intake assessed by a frequency food questionnaire	baseline
Other	dairy products	frequency of intake assessed by a frequency food questionnaire	baseline
Other	fats	frequency of intake assessed by a frequency food questionnaire	baseline
Primary	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	Baseline
Secondary	exposure to viral hepatitis C	binary yes / undiagnosed by positive serology for positive anti-HCV antibodies	baseline