Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
ConditionHepatic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity Hospital, Grenoble
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients between 18 and 70 years of age
FIB-4 2.67
Patients covered by Health Insurance System
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov