Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatic Fibrosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- 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 [Time frame: up to 14 months]
- Evaluation of diagnoses of advanced hepatic fibrosis made during the study compared to the expected disease frequency [Time frame: up to 14 months]
Secondary outcome measures (4)
- Among all patients with calculated FIB-4 scores, evaluate the proportion of patients eligible for a specialized hepatic fibrosis assessment test. [Time frame: up to 12 months]
- Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months. [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. [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 [Time frame: up to 14 months]
Eligibility criteria
Inclusion criteria
- Patients between 18 and 70 years of age
- FIB-4 2.67
- Patients covered by Health Insurance System
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Grenoble Alpes — Grenoble
Identifiers
NCT: NCT06119997 · 38RC22.0266