LIVER FIBROSIS PREVALENCE IN FRANCE (FIBROFRANCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
DRCD12, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01927133
First received: June 14, 2013
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

"Mortality related to complications of cirrhosis, (hemorrhage, hepatic insufficiency and primary liver cancer) is 15,000 per year in France. These mortality increases, despite that advanced fibrosis can be identified by non-invasive biomarkers and treated, more than 10 years before the onset of complications and cancer. The main goals of the FIBROFRANCE project which started in 1997 (initially called the MULTIVIRC group) were to demonstrate the performance of serum biomarkers in the more frequent chronic liver diseases, to estimate the dynamic of fibrosis progression and finally to demonstrate the feasibility of the fibrosis screening in French people.

The different cohorts of the FIBROFRANCE (HCV, HBV, ALD, NAFLD) permitted many publications among the 186 publications of our group since 1986 in the field of liver fibrosis. These publications included discovery and validation of non-invasive biomarkers (Poynard Gastroenterology 1997, Imbert-Bismut Lancet 2001, Poynard BMC Gastro 2007), modelling fibrosis progression or regression (Poynard Lancet 1997, Poynard Gastroenterology 2002, Poynard J Hepatol 2003) and fibrosis screening (Ratziu APT 2007, Jacqueminet Clin Gastrenterol Hepatol 2008). This research was conducted in Pitié-Salpêtrière hospital for the biochemical and clinical part in connection with national and international networks. Several panels have been identified and the most predictive FibroTest has been patented (US Patent Office 6.631.330) and launched in 2002. This is the first fibrosis biomarker available worldwide (50 countries including USA as FibroSURE) with more than 1 million prescriptions between 2002-2013. FibroTest, has been validated first in hepatitis C and then in hepatitis B alcoholic liver disease and metabolic syndrome. Therefore it is now possible to screen advanced fibrosis in the 4 most frequent liver diseases: alcohol, hepatitis C and B, and metabolic syndrome (diabetes, overweight, and hyperlipemia). For all the patients detected there are therapeutic options to cure the fibrosis or to reduce the progression to cirrhosis and cancer.

FibroTest has been recommended as alternative to biopsy in several guidelines (AFEF, APASL, EASL and CASLD) and more recently in US overview (Chou Annals 2013). It reimbursed in France in chronic hepatitis C. Several factors of fibrosis progression can be present in the same subject, i.e. an overweight and an excessive alcohol consumption. Therefore no realistic screenng strategy can be conducted without taking into account the Interdependence of the different risk factors. Three biomarkers of fibrosis-associated liver injuries have been developed and validated in FIBROFRANCE cohorts: SteatoTest for steatosis (Poynard Comp Hepatol 2005), NashTest for non-alcoholic steatohepatitis (Poynard EASL 2006), and AshTest for alcoholic steatohepatitis (Naveau J Hepatol 2006). For this purpose different cohorts already used for diagnostic validation will be followed at long term for prognostic validations: FIBROFRANCE-ALD (Naveau Hepatology 2010), FIBROFRANCE-NAFLD including dyslipidemia cohort (Ratziu APT 2007) and diabetes cohort (Jacqueminet Clin Gastrenterol Hepatol 2008). These cohorts will allow assessing the prevalence of fibrosis and the specific risks of fibrosis progression imputable to steatosis and steatohepatitis.


Condition
Liver Fibrosis Progression in Chronic Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Fibrosis progression rate [ Time Frame: From first biomarker date to first clinical event ] [ Designated as safety issue: No ]
    At least one year follow up for fibrosis progression rate.


Secondary Outcome Measures:
  • Overall survival, survival without related complications [ Time Frame: From first biomarker date to first clinical event ] [ Designated as safety issue: No ]
    For Mortality and Morbidity one assessment at five years and one assessment at 10 years.


Biospecimen Retention:   Samples With DNA

Serum, liver biopsy


Estimated Enrollment: 10000
Study Start Date: January 1997
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
FIBROFRANCE Project

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Population with chronic liver disease followed in tertiary centers

Criteria

Inclusion Criteria:

-Patients Exposed to fibrosis risk factors (HBV, HCV, ALD, NAFLD) or healthy volunteers

Exclusion Criteria:

-Non reliable fibrosis estimate, follow up shorter than months, acute liver diseases

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927133

Contacts
Contact: Thierry POYNARD 00 33 1 42 16 10 22 tpoynard@teaser.fr
Contact: Vlad RATZIU 00 33 1 42 16 10 02 vratziu@teaser.fr

Locations
France
Hôpital Pitié-Salpêtrière Recruiting
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: DRCD12, Professor Thierry POYNARD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01927133     History of Changes
Other Study ID Numbers: DRCD2013-01
Study First Received: June 14, 2013
Last Updated: August 21, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fibrosis, HBV, HCV, ALD, NAFLD

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014