Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD
Official title: Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)
Run by Hospital General Universitario Gregorio Marañon · NCT07658755 · Data updated 2026-11-12
This program automatically screens high‑risk adults aged 50–75 in primary care to see if they have advanced liver fibrosis and possible MASLD, using routine blood tests and reflex lab tests without extra work for clinicians.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years to 75 Years |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | June 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07658755 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 50–75 with a routine blood test showing either ALT above normal with HbA1c ≥6.5%, ALT above normal with BMI >30, or BMI >30 with HbA1c ≥6.5, across 11 affiliated primary care centers in Madrid.
✕Probably not a fit
Patients without metabolic risk factors or with normal non-invasive marker results may not benefit from this screening pathway.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
LiverSeek is an automated, passive screening program that analyzes existing routine blood tests from primary care patients to identify those at risk for advanced liver fibrosis due to MASLD. The Laboratory Information System automatically calculates the FIB-4 score and, if above the threshold, reflexively orders ELF and MASEF from the same sample; positive results trigger further hepatology evaluation. The approach aims to close gaps in guideline-based screening that rely on clinician-initiated assessments, by removing the burden from primary care. If non-invasive markers indicate potential disease, patients proceed to specialist assessment, imaging, and, if indicated, biopsy per clinical criteria. A histological sub-study will characterize liver biopsy samples for disease activity and fibrosis.
Why it matters
Potential benefit: If successful, the approach could increase timely identification of advanced fibrosis in MASLD, enabling earlier specialist involvement and management.
How similar studies have gone: Prior programs relied on clinician-initiated screening; LiverSeek uses a passive LIS-driven approach that is relatively novel but builds on established non-invasive tests like FIB-4, ELF, and MASEF.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 50 and 75 years (inclusive) 2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres 3. Presence of at least one of the following metabolic risk factor combinations: * ALT above the upper limit of normal AND HbA1c ≥6.5% * ALT above the upper limit of normal AND BMI \>30 kg/m² * BMI \>30 kg/m² AND HbA1c ≥6.5% Exclusion Criteria: 1. Age \<50 years or \>75 years 2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation) 3. Prior fibrosis assessment within the preceding 12 months.
Where it's running
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Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Luis Ibáñez-Samaniego, MD, PhD
- Email: luis.ibanez@salud.madrid.org
- Phone: +34 91 586 8308
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.