An observational study in Hepatic Fibrosis, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by University Hospital, Grenoble · Observational
Liver fibrosis screening is possible at the asymptomatic stage through a healthcare management strategy currently recommended for patients with risk factors for chronic liver disease. It is based on a sequential strategy involving a 1st-line test, fibrosis score calculation (FIB-4).
Given this opportunity to identify advanced fibrosis in asymptomatic patients, the project aims to set up this screening program in the Grenoble area with Biogroup Laboratories, in collaboration with the Hepato-gastroenterology department (HGE) of Grenoble University Hospital. The aim of this study is to evaluate the success of sequential screening using FIB-4, followed by a specialized fibrosis test for the diagnosis of advanced hepatic fibrosis
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 500 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study Population (FIB-4 ≥2.67):
The expected frequency of advanced fibrosis in the study population (= positive predictive value) is estimated at 14%, based on literature data (sensitivity and specificity of FIB-4 ≥2.67 for the diagnosis of advanced fibrosis at 32% and 96%, prevalence of advanced fibrosis at 2% in the screened population (10)). Assuming adherence to recommendations to achieve a 10% diagnosed liver fibrosis, corresponding to a non-inferiority margin of 4% compared to the theoretical percentage of 14%, 441 patients are required (power at 80%, alpha risk at 5%, binomial test for a single sample). This sample size will be extended to 500 patients with FIB-4 ≥2.67, taking potential attrition into account.
Exclusion Criteria:
Evaluate the sequential screening of advanced hepatic fibrosis in primary care using an automatic calculation of FIB-4 followed by the use of a specialized non-invasive fibrosis test
Percentage of patients with advanced hepatic fibrosis (fibrosis at least equivalent to stage F3 or F4 according to METAVIR at the end of the evaluation by the hepatogastroenterologist) diagnosed among patients with no known HCV infection and FIB-4 ≥2.67
Time frame: up to 14 months
Evaluation of diagnoses of advanced hepatic fibrosis made during the study compared to the expected disease frequency
Proportion of diagnoses made at 14 months to the expected disease frequency among patients with no known HCV infection and FIB-4 ≥2.67
Time frame: up to 14 months
Among all patients with calculated FIB-4 scores, evaluate the proportion of patients eligible for a specialized hepatic fibrosis assessment test.
Proportion of patients with FIB-4 ≥2.67 among patients who underwent FIB-4 calculation or the screened population.
Time frame: up to 12 months
Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months.
Proportion among patients with FIB-4 ≥2.67 who have received appropriate medical care, defined by the performance of a specialized test and a specialist consultation if the test is positive.
Time frame: up to 14 months
Evaluate, among patients diagnosed with advanced fibrosis, the proportion of specialized follow-ups compliant with recommendations at 14 months.
Proportion among patients with advanced fibrosis who have had at least one specialist consultation, and for patients with cirrhosis, a semi-annual screening ultrasound for HCC within 14 months.
Time frame: up to 14 months
Description of social and clinical determinants associated with the diagnosis of advanced fibrosis and the quality of follow-up at 14 months
Estimation of crude and adjusted relative risks for advanced liver fibrosis and non-compliant follow-up associated with the following variables: age, sex, smoking, diabetes, obesity, sleep apnea syndrome, high blood pressure, dyslipidemia, alcohol consumption, screening for alcohol-related risks, physical activity, medical history, current treatments, level of education, socio-professional category, assessment of precariousness, existence of situations of non-use of healthcare
Time frame: up to 14 months
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University Hospital, Grenoble