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

NCT03852238 | Completed

• 1 other identifier: CHUBX 2010/03
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 14

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).

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; Non-cirrhotic liver; Risk factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• exposure to viral hepatitis C

  baseline

Other Outcomes (19)

• exposure to Alcohol

  baseline

• exposure to Exogenous female hormones

  baseline

• history of liver pathology

  baseline

Study Arms (2)

Cases: patients with hepatocellular carcinoma on non-cirrhotic

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

Control: patients without hepatocellular carcinoma

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

Interventions

Blood test and self-administrated questionnaires OTHER

Control: patients without hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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) \- CONTROLS: patients without NfHCC at baseline

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• National Cancer Institute, France: collaborator

Study Sites (14)

CHU Amiens

Amiens, France

Location

AP-HP Jean Verdier

Bondy, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Caen

Caen, France

Location

AP-HP Hopital Antoine Béclère

Clamart, France

Location

AP-HP Hopital Beaujon

Clichy, France

Location

CHI Créteil

Créteil, France

Location

CHU Grenoble

Grenoble, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Hospices Civiles de Lyon

Lyon, France

Location

AP-HP Cochin

Paris, France

Location

AP-HP Hopital Henri Mondor

Paris, France

Location

AP-HP Hopital Saint Antoine

Paris, France

Location

CHU Villejuif

Villejuif, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 25, 2019
• Study Start: August 18, 2010
• Primary Completion: November 14, 2013
• Study Completion: November 14, 2013
• Last Updated: February 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)