NCT07658755 Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme
| NCT ID | NCT07658755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital General Universitario Gregorio Marañon |
| Condition | Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2024-10-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Rafael Bañares, Full-Professor of Medicine
STUDY CHAIR
Universidad Complutense de Madrid, President of Spanish Association for the Study of the Liver (AEEH)
Frequently Asked Questions
Who can join the NCT07658755 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Metabolic Dysfunction-Associated Steatotic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07658755 currently recruiting?
Yes, NCT07658755 is actively recruiting participants. Contact the research team at luis.ibanez@salud.madrid.org for enrollment information.
Where is the NCT07658755 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07658755 clinical trial?
NCT07658755 is sponsored by Hospital General Universitario Gregorio Marañon. The principal investigator is Rafael Bañares, Full-Professor of Medicine at Universidad Complutense de Madrid, President of Spanish Association for the Study of the Liver (AEEH). The trial plans to enroll 3,000 participants.