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NCT Number: NCT07031089

City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area

Cirrhosis and hepatocellular carcinoma (HCC) are responsible for 25,000 deaths per year in France. The main causes are excessive alcohol consumption, metabolic steatosis, and hepatitis B and C. Fibrosis, classified from F0 (absence of fibrosis) to F4 (cirrhosis), is the sole determinant of liver-related mortality, particularly from stage F3. The incidence of metabolic steatosis is increasing, associated with a rise in mortality from chronic liver diseases (CLD). CLDs, often asymptomatic, are diagnosed late, reducing patient survival. Recommendations exist for the screening of hepatic fibrosis in at-risk patients (alcohol, diabetes, metabolic syndrome). This screening relies on calculating the FIB-4 score (calculated from widely prescribed variables: AST, ALT, platelets, age), followed by Fibroscan® (a non-invasive test for hepatic fibrosis) if FIB-4 > 1.3.

A Fibroscan® result <8kPa excludes advanced fibrosis, while a result >9.6kPa suggests advanced fibrosis and ≥15kPa indicates cirrhosis. The appropriate care pathway includes a risk reduction program, a specialized consultation for patients with Fibroscan® ≥8kPa, and semi-annual screening for HCC in the case of cirrhosis. Indeed, it has been shown in a French cohort of patients with viral C cirrhosis that adherence to semi-annual screening is associated with better survival.

Eligible patients are primarily seen in primary care, and INCA has published a recommendation intended for general practitioners to improve the screening of fibrosis [13]. However, FIB-4 is poorly known among general practitioners [14], and access to Fibroscan® remains limited [15], hindering the implementation of the recommendations. Therefore, a care pathway has been established in the Grenoble area, initiated by Professor Costentin, allowing access to Fibroscan® for patients in primary care, starting from 2022 at the CHU. The objective is to evaluate the completion of the pathway, particularly the management of MCF risk factors and referral to specialized consultation for patients with Fibroscan® ≥8 kPa.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Communauté Professionnelle Territoriale de Santé Sud Est Grenoblois, Grenoble, France

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Who can participate

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

Inclusion criteria

  • Patients aged 18 years or older
  • Having undergone a Fibroscan® at the CHU de Grenoble-Alpes or CPTS-SEG, requested by a primary care practitioner (general practitioner, non-hospital diabetologist, Asalée nurse), as part of the screening recommendations for liver fibrosis in the case of a FIB4 score > 1.3
  • With a result ≥ 8kPa
  • Between January 2023 and January 2026

Exclusion criteria

  • Patients who have expressed their opposition to participating in the study
  • Patients under guardianship or deprived of liberty
  • Patients with a known chronic liver disease who are being monitored at the time of the Fibroscan® procedure

Treatment and study plan

Non-interventional study (RIPH category 3)

Other

The study aims to describe and evaluate an existing care pathway, implemented within the framework of current clinical practice, without modifying the modalities of care or adding specific interventions. No additional procedures are imposed on participants, apart from data collection for evaluation purposes and telephone interviews.

Primary outcomes

  1. Evaluation of managment of risk factors for significant liver fibrosis.

    Time frame: Up to 30 months

    Proportion of patients with Fibroscan® ≥ 8kPa who received a specialized consultation in hepatogastroenterology in the year following the Fibroscan®

Secondary outcomes

  1. Frequency of risk factors for liver fibrosis.

    Time frame: Up to 30 months

    proprtion of patient with risk factors for liver fibrosis.

  2. Evaluation of managment of risk factors for liver fibrosis.

    Time frame: Up to 30 months

    Proportion of patients who received appropriate management of identified risk factors.

  3. Evaluation of patients satisfaction after

    Time frame: Up to 30 months

    Proportion of patients who satisfied with their care pathway evaluted with the 'patient' satisfaction and difficulties questionnaire .

  4. Evaluation of social determinals of health associated to the risks of advanced of liver fibrosis.

    Time frame: up to 30 months

    Estimation of the risks of advanced liver fibrosis according to the above definition associated with predefined variables of interest.

  5. Evaluation of managment of risk factors for significant liver fibrosis in chu Grenoble Alpes patients .

    Time frame: up to 30 months

    Main judgment criterion estimated among patients screened at the university hospital.

  6. Evaluation of the proportion of patients who had at least one specialized consultation within 12 months.

    Time frame: up to 30 months

    Proportion of patients who had at least one specialized consultation in 12 months.

Study contacts

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

Anna Borowik, PhD

CONTACT

[email protected]

+33476769314

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: PREFIB

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 22, 2025
Registry last updated
Mar 2, 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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