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.
Age between 50 and 75 years (inclusive)
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
ALT above the upper limit of normal AND HbA1c ≥6.5%
ALT above the upper limit of normal AND BMI >30 kg/m²
Age <50 years or >75 years
Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)
Prior fibrosis assessment within the preceding 12 months.
Patients attending primary care in peri-urban Madrid (SERMAS network) with metabolic risk factors for liver fibrosis, identified passively through routine laboratory data
Cohort
Prospective
Not listed
Prevalence of hepatic fibrosis detected by the automated single-step case-finding strategy
Proportion of high-risk patients with a positive result on at least one confirmatory NIT (ELF ≥9.8, MASEF ≥0.33, or VCTE ≥8.0 kPa) among all patients in whom FIB-4 was automatically calculated by the LIS
Diagnostic accuracy of FIB-4+ELF versus FIB-4+MASEF for histologically-confirmed significant fibrosis (≥F2)
Head-to-head AUROC comparison (DeLong method) of sequential NIT algorithms at pre-specified thresholds (ELF ≥9.8; MASEF ≥0.33) in biopsied patients. Sensitivity, specificity, PPV, NPV reported.
Diagnostic accuracy of sequential NIT algorithms for at-risk MASH
AUROC comparison of FIB-4+ELF, FIB-4+MASEF, and FIB-4+FAST (threshold ≥0.50) for histological at-risk MASH (NAS ≥4 + fibrosis ≥F2, Kleiner criteria) in biopsied patients
Cost-effectiveness of the automated single-step strategy versus standard of care
Health-economic analysis: diagnostic yield per euro spent, cost per case detected, and cost per QALY gained
Click on the lead sponsor to view all of their trials.
Hospital General Universitario Gregorio Marañon
Lead sponsor
Instituto de Investigación Sanitaria Gregorio Marañón
Collaborator
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborator
