Automatic blood-test screening for advanced liver scarring in people with fatty liver disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 50 to 75 who have a routine blood test in primary care and are at higher risk of liver scarring linked to metabolic liver disease.

Age

50 to 75 years (inclusive)

Sex

All sexes

Disease stage

Higher-risk people for liver scarring (fibrosis) linked to metabolic liver disease; they must have one of these combinations: ALT above the upper limit of normal and HbA1c ≥6.5% (48 mmol/mol); ALT above the upper limit of normal and BMI >30 kg/m²; BMI >30 kg/m² and HbA1c ≥6.5% (48 mmol/mol).

Earlier treatment

No liver scarring check (fibrosis assessment) in the previous 12 months.

Biomarker or test result

Blood test results: ALT above the upper limit of normal, HbA1c ≥6.5% (48 mmol/mol), or BMI >30 kg/m², in the combinations listed above.

Main reasons for not taking part

• Younger than 50 or older than 75
• Known liver disease already (significant or advanced fibrosis, cirrhosis, liver cancer, prior liver transplant)
• Liver scarring assessed in the previous 12 months

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 50 and 75 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• NIT-Negative Cohort

  High-risk patients (age 50-75 years with ≥1 metabolic risk criterion) in whom FIB-4 was automatically calculated by the LIS and found to be ≤1.30. These patients do not undergo further NIT evaluation and are followed as the non-exposed reference cohort.

• NIT-Positive Cohort

  High-risk patients with FIB-4 \>1.30 in whom ELF and MASEF were reflexively determined from the same serum sample. Patients with ELF ≥9.8 or MASEF ≥0.33 are referred to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical assessment.