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

NCT07658755 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-06-22

No results posted yet for this study

Summary

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, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Liver Fibrosis
  • Non-alcoholic Fatty Liver Disease NAFLD
  • Type 2 Diabetes Mellitus
  • Obesity
  • Obesity Type 2 Diabetes Mellitus

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Gregorio Marañón

    collaborator OTHER

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    collaborator OTHER_GOV

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Rafael Bañares, Full-Professor of Medicine · Universidad Complutense de Madrid, President of Spanish Association for the Study of the Liver (AEEH)

  • Magdalena Salcedo, MD, PhD · President of the Spanish Society of Liver Transplantation (SETH)

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-06-01
Completion
2027-09-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658755 on ClinicalTrials.gov