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

Recruitingn/aAges 50 Years - 75 YearsAllHospital General Universitario Gregorio Marañon
NCT07658755 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Hospital General Universitario Gregorio Marañón
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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