Hepatic FibrosisANTICIP-SPNCT06119997
Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
An observational study of Hepatic Fibrosis, run by University Hospital, Grenoble at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Fibrosis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2025to 30 Jul 2028
- 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 to 70 years
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- Patients between 18 and 70 years of age
- FIB-4 2.67
- Patients covered by Health Insurance System
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble
Charlotte COSTENTIN, Pr
About this study
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
- Conditions
- Hepatic Fibrosis
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 14 months
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
Measured: up to 14 months
Secondary outcomes (4)
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.
Measured: up to 12 months
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.
Measured: up to 14 months
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.
Measured: up to 14 months
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
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start26 Jun 2025
- Primary completion25 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 500 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
- NCT06119997
- Sponsor's protocol ID
- 38RC22.0266
- Acronym
- ANTICIP-SP
- Status last verified
- May 2026
- First submitted
- 12 Oct 2023
- Last updated
- 20 May 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Advanced Liver Fibrosis Using Non-invasive Tests in Primary Care
- ClinicalTrials.gov ID
- NCT06119997
- Acronym / sponsor ID
- ANTICIP-SP / 38RC22.0266
- Conditions
- Hepatic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 25 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 7 Nov 2023 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Patients between 18 and 70 years of age
- FIB-4 2.67
- Patients covered by Health Insurance System
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
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
Evaluate, among patients with FIB-4 ≥2.67, the proportion of pathways compliant at 14 months.
Time frame: up to 14 months
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
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
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 20 May 2026.
Related trials for Hepatic Fibrosis
RecruitingPhase 2
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
Liver Fibrosis, Hepatic Cirrhosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Fibrosis, run by University Hospital, Grenoble at 1 site 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 3 inclusion and 4 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Charlotte Costentin, Pr (+33476769368, ccostentin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 20 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.