Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care

NCT06119997 | Not Yet Recruiting

• 1 other identifier: 38RC22.0266
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to 14 months

Secondary Outcomes (4)

• Among all patients with calculated FIB-4 scores, evaluate the proportion of patients eligible for a specialized hepatic fibrosis assessment test.

  up to 12 months

• Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months.

  up to 14 months

• Evaluate, among patients diagnosed with advanced fibrosis, the proportion of specialized follow-ups compliant with recommendations at 14 months.

  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

  up to 14 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients between 18 and 70 years of age
• FIB-4 2.67
• Patients covered by Health Insurance System

You may not qualify if:

• Prescription triggering FIB-4 emanate from a hepatogastroenterologist or oncologist
• Conditions associated with high risk false-positive FIB-4: ASAT or ALAT \> 300 IU/L, platelets \<50 G/L or \>500 G/L.
• Patient refusing to participate
• Subjects under guardianship or deprived of liberty

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charlotte Costentin

CONTACT

+33476769368; ccostentin@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 7, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-04