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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01927133
Recruitment Status : Unknown
Verified August 2013 by DRCD12, Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Information provided by (Responsible Party):
DRCD12, Assistance Publique - Hôpitaux de Paris

Brief Summary:

"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 or disease
Liver Fibrosis Progression in Chronic Liver Disease

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 1997
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


Primary Outcome Measures :
  1. Fibrosis progression rate [ Time Frame: From first biomarker date to first clinical event ]
    At least one year follow up for fibrosis progression rate.

Secondary Outcome Measures :
  1. Overall survival, survival without related complications [ Time Frame: From first biomarker date to first clinical event ]
    For Mortality and Morbidity one assessment at five years and one assessment at 10 years.

Biospecimen Retention:   Samples With DNA
Serum, liver biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Population with chronic liver disease followed in tertiary centers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01927133

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Contact: Thierry POYNARD 00 33 1 42 16 10 22
Contact: Vlad RATZIU 00 33 1 42 16 10 02

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Hôpital Pitié-Salpêtrière Recruiting
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
9121257 9181529 9500720 9922319 10524695 10833486 1297957 11481613 12081607 12358267 12537583 12586290 12645802 12646795 12873819 15080567 15192028 15214966 15565616 16584387 16765932 16771947 16931569 17229244 17311607 17634213 17635370 17767469 18524692 18596917 19011575 19052646 19053048 19610141 20412588 21354889 21634051

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: DRCD12, Professor Thierry POYNARD, Assistance Publique - Hôpitaux de Paris Identifier: NCT01927133    
Other Study ID Numbers: DRCD2013-01
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by DRCD12, Assistance Publique - Hôpitaux de Paris:
Fibrosis, HBV, HCV, ALD, NAFLD
Additional relevant MeSH terms:
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Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases