Liver FibrosisPREFIBNCT07031089
City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area
An observational study of Liver Fibrosis, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Non-interventional study (RIPH category 3)
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jan 2026to 14 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients from the Grenoble area underwent a Fibroscan® at CHU Grenoble Alpes or CPTS-SEG, upon request by a primary care practitioner, as part of hepatic fibrosis screening (FIB-4 >1.3, Fibroscan® ≥8kPa). Eligible patients will be contacted by a clinical research associate for a telephone questionnaire.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Communauté Professionnelle Territoriale de Santé Sud Est Grenoblois
Grenoble
Laura Hyerle, MD, +33 4 76 24 04 81, laura.hyerle@univ-grenoble-alpes.fr
- Recruiting
Grenoble Alpes University Hospital
Grenoble
Anna Borowik, PhD, +33 4 76 76 93 14, aborowik@chu-grenoble.fr
About this study
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.
- Conditions
- Liver Fibrosis
- Being tested
- Non-interventional study (RIPH category 3)
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of managment of risk factors for significant liver fibrosis.
Proportion of patients with Fibroscan® ≥ 8kPa who received a specialized consultation in hepatogastroenterology in the year following the Fibroscan®
Measured: Up to 30 months
Secondary outcomes (6)
Frequency of risk factors for liver fibrosis.
proprtion of patient with risk factors for liver fibrosis.
Measured: Up to 30 months
Evaluation of managment of risk factors for liver fibrosis.
Proportion of patients who received appropriate management of identified risk factors.
Measured: Up to 30 months
Evaluation of patients satisfaction after
Proportion of patients who satisfied with their care pathway evaluted with the 'patient' satisfaction and difficulties questionnaire .
Measured: Up to 30 months
Evaluation of social determinals of health associated to the risks of advanced of liver fibrosis.
Estimation of the risks of advanced liver fibrosis according to the above definition associated with predefined variables of interest.
Measured: up to 30 months
Evaluation of managment of risk factors for significant liver fibrosis in chu Grenoble Alpes patients .
Main judgment criterion estimated among patients screened at the university hospital.
Measured: up to 30 months
Evaluation of the proportion of patients who had at least one specialized consultation within 12 months.
Proportion of patients who had at least one specialized consultation in 12 months.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start14 Jan 2026
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031089
- Sponsor's protocol ID
- 2025-A010187-42
- Acronym
- PREFIB
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the Grenoble Health Area
- ClinicalTrials.gov ID
- NCT07031089
- Acronym / sponsor ID
- PREFIB / 2025-A010187-42
- Conditions
- Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Jan 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the Grenoble area underwent a Fibroscan® at CHU Grenoble Alpes or CPTS-SEG, upon request by a primary care practitioner, as part of hepatic fibrosis screening (FIB-4 >1.3, Fibroscan® ≥8kPa). Eligible patients will be contacted by a clinical research associate for a telephone questionnaire.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional study (RIPH category 3)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. | Other | – |
Primary outcome
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®
6 secondary outcomes
Frequency of risk factors for liver fibrosis.
Time frame: Up to 30 months
Evaluation of managment of risk factors for liver fibrosis.
Time frame: Up to 30 months
Evaluation of patients satisfaction after
Time frame: Up to 30 months
Evaluation of social determinals of health associated to the risks of advanced of liver fibrosis.
Time frame: up to 30 months
Evaluation of managment of risk factors for significant liver fibrosis in chu Grenoble Alpes patients .
Time frame: up to 30 months
Evaluation of the proportion of patients who had at least one specialized consultation within 12 months.
Time frame: up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Borowik, PhD (+33476769314, aborowik@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of managment of risk factors for significant liver fibrosis. (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.