Screening for advanced liver fibrosis using non-invasive tests
SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
NA · University Hospital, Angers · NCT05880173
This study is testing if using simple blood tests to screen people with high FIB4 scores can help find advanced liver fibrosis earlier in those at risk for serious liver problems.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 502 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Angers (other gov) |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT05880173 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of initiating screening for advanced hepatic fibrosis in individuals with a FIB4 score greater than 2.67, which is automatically calculated in local laboratories. The study focuses on identifying patients at high risk for complications related to chronic liver diseases, such as cirrhosis and hepatocellular carcinoma. By utilizing non-invasive tests like the FIB4 blood test and liver elastometry, the study seeks to improve early detection and management of advanced liver fibrosis. Participants will undergo specialized hepatic evaluations based on their FIB4 results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who have a FIB4 score greater than 2.67 and meet specific blood test criteria.
Not a fit: Patients currently undergoing specialized follow-up for chronic liver disease or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of advanced liver fibrosis, potentially reducing the risk of severe liver complications.
How similar studies have performed: Other studies have shown success with similar non-invasive screening approaches for liver fibrosis, indicating a promising avenue for early detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 70 years * Blood sample taken at a medical testing laboratory selected for the study. * Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and \< 500 G/l.) * FIB4 \> 2.67 after automatic calculation in the medical laboratory less than 3 months old * Signature of informed consent to participate in the study Exclusion Criteria: * Ongoing specialized follow-up for a chronic liver disease * Difficulty understanding the French language * Pregnant women, breastfeeding or parturient women * Persons suspended from liberty by judicial or administrative decision * Persons under legal protection * Persons unable to express their consent * Non affiliation to a social security system
Where this trial is running
Angers and 5 other locations
- Chu Angers — Angers, France (NOT_YET_RECRUITING)
- Chu Bordeaux — Angers, France (NOT_YET_RECRUITING)
- Chu Grenoble Alpes — Grenoble, France (RECRUITING)
- Centre Hospitalier de Lens — Lens, France (RECRUITING)
- Hopital Saint Joseph — Marseille, France (NOT_YET_RECRUITING)
- Chu Nancy — Nancy, France (RECRUITING)
Study contacts
- Study coordinator: Clémence CANIVET, MD, PHD
- Email: clemence.canivet@chu-angers.fr
- Phone: (0)241353142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Screening, Advanced Liver Fibrosis, advanced liver fibrosis, non-invasive tests