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

Hepatic Fibrosis Clinical Trial

— ANTICIP-SP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119997
• Other study ID #: 38RC22.0266
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients between 18 and 75 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

Related Conditions & MeSH terms

• Fibrosis
• Hepatic Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	up to 12 months
Secondary	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.	up to 14 months
Secondary	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.	up to 14 months
Secondary	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	up to 14 months