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Study identifier: NCT07658755 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme

Condition: Metabolic Dysfunction-Associated Steatotic Liver Disease · Liver Fibrosis · Non-alcoholic Fatty Liver Disease NAFLD  ·  Sponsor: Hospital General Universitario Gregorio Marañon

PhaseN/A
Planned participants3000
Who can joinAll sexes, 50 Years to 75 Years
Healthy volunteersNo

About this study

LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab/Biwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain. When a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \>30; BMI \>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation. The primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, an…

This description comes directly from the study's public registry record.

Talk to the study team

Luis Ibáñez-Samaniego, MD, PhD  ·  +34 91 586 8308  ·  luis.ibanez@salud.madrid.org

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital General Universitario Gregorio MarañónMadrid, Madrid, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT07658755