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临床试验/NCT01927133
NCT01927133Unknown不适用

LIVER FIBROSIS PREVALENCE IN FRANCE

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 1997年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Fibrosis progression rate

研究概览

简要总结

"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.

详细描述

"This is the initial version of the FIBROFRANCE project which strated in 1997. Methods The strategy chosen is to screen advanced fibrosis in several groups of patients with different levels of risks in order to reconstruct the French prevalence thereafter. A national screening will be suggested according to the identified risk factors.

Rational and prior hypothesis The simple rational concept is to screen patients before complications of cirrhosis. (Figure 1).

Figure 1: Fibrosis progression with five consecutive stages: F0 no fibrosis, F1 mild fibrosis without septa, F2 moderate fibrosis with few septa, F3 severe fibrosis with many septa, F4 cirrhosis.

Advanced fibrosis is defined by presence of stages F2-F3-F4. The aim of the study is to demonstrate that the screening is possible at stage F2 many years before complications. From previous modeling (Figure 2) we suggested that an efficient screening must start around the age of 40 years for the majority of high-risk group and around 30 years old in HIV coinfected patients.

Population included Five major groups and 15 cohorts of different populations at risk will be included. Five groups at high risk will be included: patients with hepatitis C, B, heavy alcohol drinkers and patients with metabolic risk factors diabetics and hyperlipemics. These populations were chosen because a blood sample can be easily available. The higher number will permit to reconstruct the French prevalence taking into account the major characteristics of subjects included (age, gender, socio economic status) and the known prevalence of some risk factors (HBV and HCV prevalence, diabetes, hyperlipemia and heavy drinker's prevalence).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Fibrosis progression rate

时间窗: From first biomarker date to first clinical event

At least one year follow up for fibrosis progression rate.

次要结局

  • Overall survival, survival without related complications(From first biomarker date to first clinical event)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DRCD12

Professor Thierry POYNARD

Assistance Publique - Hôpitaux de Paris

研究点 (1)

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