Clinical trial NCT06119997: Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
Official title: Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatic Fibrosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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

Primary outcomes:
measure: 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
timeFrame: up to 14 months
measure: Evaluation of diagnoses of advanced hepatic fibrosis made during the study compared to the expected disease frequency
timeFrame: up to 14 months
Secondary outcomes:
measure: Among all patients with calculated FIB-4 scores, evaluate the proportion of patients eligible for a specialized hepatic fibrosis assessment test.
timeFrame: up to 12 months
measure: Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months.
timeFrame: up to 14 months
measure: Evaluate, among patients diagnosed with advanced fibrosis, the proportion of specialized follow-ups compliant with recommendations at 14 months.
timeFrame: up to 14 months
measure: Description of social and clinical determinants associated with the diagnosis of advanced fibrosis and the quality of follow-up at 14 months
timeFrame: up to 14 months
Other outcomes:
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Study officials:
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