LIVER FIBROSIS PREVALENCE IN FRANCE

NCT01927133 | Unknown

• 1 other identifier: DRCD2013-01
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis Progression in Chronic Liver Disease

Keywords

Fibrosis, HBV, HCV, ALD, NAFLD

Outcome Measures

Primary Outcomes (1)

• Fibrosis progression rate

  At least one year follow up for fibrosis progression rate.

  From first biomarker date to first clinical event

Secondary Outcomes (1)

• Overall survival, survival without related complications

  From first biomarker date to first clinical event

Study Arms (1)

FIBROFRANCE Project

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population with chronic liver disease followed in tertiary centers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, Paris, France

RECRUITING

Related Publications (8)

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  BACKGROUND

• Maisonnasse P, Poynard T, Sakka M, Akhavan S, Marlin R, Peta V, Deckmyn O, Ghedira NB, Ngo Y, Rudler M, van der Werf S, Marot S, Thabut D, Sokol H, Housset C, Combes A, Le Grand R, Cacoub P. Validation of the Performance of A1HPV6, a Triage Blood Test for the Early Diagnosis and Prognosis of SARS-CoV-2 Infection. Gastro Hep Adv. 2022;1(3):393-402. doi: 10.1016/j.gastha.2021.12.009. Epub 2022 Feb 7.

  PMID: 35174366 DERIVED

• Poynard T, Deckmyn O, Rudler M, Peta V, Ngo Y, Vautier M, Akhavan S, Calvez V, Franc C, Castille JM, Drane F, Sakka M, Bonnefont-Rousselot D, Lacorte JM, Saadoun D, Allenbach Y, Benveniste O, Gandjbakhch F, Mayaux J, Lucidarme O, Fautrel B, Ratziu V, Housset C, Thabut D, Cacoub P. Performance of serum apolipoprotein-A1 as a sentinel of Covid-19. PLoS One. 2020 Nov 20;15(11):e0242306. doi: 10.1371/journal.pone.0242306. eCollection 2020.

  PMID: 33216772 DERIVED

• Poynard T, Peta V, Deckmyn O, Pais R, Ngo Y, Charlotte F, Ngo A, Munteanu M, Imbert-Bismut F, Monneret D, Housset C, Thabut D, Valla D, Boitard C, Castera L, Ratziu V; FLIP consortium, the FibroFrance Group, the EPIC-3 program and the QUID-NASH group. Performance of liver biomarkers, in patients at risk of nonalcoholic steato-hepatitis, according to presence of type-2 diabetes. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):998-1007. doi: 10.1097/MEG.0000000000001606.

  PMID: 31789950 DERIVED

• Poynard T, Peta V, Deckmyn O, Munteanu M, Moussalli J, Ngo Y, Rudler M, Lebray P, Pais R, Bonyhay L, Charlotte F, Thibault V, Fartoux L, Lucidarme O, Eyraud D, Scatton O, Savier E, Valantin MA, Ngo A, Drane F, Rosmorduc O, Imbert-Bismut F, Housset C, Thabut D, Ratziu V; HECAM-FibroFrance Group. LCR1 and LCR2, two multi-analyte blood tests to assess liver cancer risk in patients without or with cirrhosis. Aliment Pharmacol Ther. 2019 Feb;49(3):308-320. doi: 10.1111/apt.15082. Epub 2018 Dec 19.

  PMID: 30569507 DERIVED

• Munteanu M, Pais R, Peta V, Deckmyn O, Moussalli J, Ngo Y, Rudler M, Lebray P, Charlotte F, Thibault V, Lucidarme O, Ngo A, Imbert-Bismut F, Housset C, Thabut D, Ratziu V, Poynard T; FibroFrance Group. Long-term prognostic value of the FibroTest in patients with non-alcoholic fatty liver disease, compared to chronic hepatitis C, B, and alcoholic liver disease. Aliment Pharmacol Ther. 2018 Nov;48(10):1117-1127. doi: 10.1111/apt.14990. Epub 2018 Oct 17.

  PMID: 30334263 DERIVED

• Poynard T, Munteanu M, Charlotte F, Perazzo H, Ngo Y, Deckmyn O, Pais R, Mathurin P, Ratziu V; FLIP consortium, the FibroFrance-CPAM group; FibroFrance-Obese group. Impact of steatosis and inflammation definitions on the performance of NASH tests. Eur J Gastroenterol Hepatol. 2018 Apr;30(4):384-391. doi: 10.1097/MEG.0000000000001033.

  PMID: 29280921 DERIVED

• Poynard T, Pham T, Perazzo H, Munteanu M, Luckina E, Elaribi D, Ngo Y, Bonyhay L, Seurat N, Legroux M, Ngo A, Deckmyn O, Thabut D, Ratziu V, Lucidarme O; FIBROFRANCE-HECAM. Real-Time Shear Wave versus Transient Elastography for Predicting Fibrosis: Applicability, and Impact of Inflammation and Steatosis. A Non-Invasive Comparison. PLoS One. 2016 Oct 5;11(10):e0163276. doi: 10.1371/journal.pone.0163276. eCollection 2016.

  PMID: 27706177 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, liver biopsy

MeSH Terms

Conditions

Fibrosis; Hepatitis B; Hepatitis C; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; Fatty Liver

Central Study Contacts

Thierry POYNARD

CONTACT

00 33 1 42 16 10 22; tpoynard@teaser.fr

Vlad RATZIU

CONTACT

00 33 1 42 16 10 02; vratziu@teaser.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Thierry POYNARD

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: August 22, 2013
• Study Start: January 1, 1997
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

FR (1)