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NCT Number: NCT06119997

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, France

Location status: Recruiting

Location contact

Charlotte COSTENTIN, Pr

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: up to 14 months

    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

  2. Evaluation of diagnoses of advanced hepatic fibrosis made during the study compared to the expected disease frequency

    Time frame: up to 14 months

    Proportion of diagnoses made at 14 months to the expected disease frequency among patients with no known HCV infection and FIB-4 ≥2.67

Secondary outcomes

  1. 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

    Proportion of patients with FIB-4 ≥2.67 among patients who underwent FIB-4 calculation or the screened population.

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

    Time frame: up to 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.

  3. 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

    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.

  4. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Costentin, Pr

CONTACT

[email protected]

+33476769368

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ANTICIP-SP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 7, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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