Prospective NAFLD/NASH patient cohort and biobank

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)

This project will collect medical data and blood/tissue samples from adults with NAFLD/NASH to create a long-term resource to help researchers understand disease course and causes.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Epatocentro Ticino (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Lugano, Canton Ticino)
• Trial ID: NCT07051863 on ClinicalTrials.gov

What this trial studies

This observational cohort will enroll adults diagnosed with NAFLD/NASH/MAFLD and gather standardized baseline and follow-up clinical data alongside a biosample repository. Diagnosis may be based on liver biopsy, imaging (ultrasound, CT, MRI, CAP) or metabolic-syndrome criteria with fibrosis or cirrhosis, and participants must consent to study procedures. Collected materials will support genetic, serologic, microbiologic and immunologic analyses and enable retrospective and prospective research on presentation, natural history, treatment responses and outcomes. The project is coordinated by Fondazione Epatocentro Ticino in Lugano and is intended as a shared resource for future investigator-led studies.

Who should consider this trial

Good fit: Adults aged 18 or older with a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino or collaborating clinicians who are willing to sign informed consent and attend study visits are ideal candidates.

Not a fit: People without NAFLD/NASH, those with an alternative primary cause of liver disease, minors, or individuals unable or unwilling to consent or attend visits at the Lugano center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the cohort and biobank could help identify risk factors, biomarkers, and targets that lead to better diagnosis, prognosis, and tailored treatments for people with NAFLD/NASH.

How similar studies have performed: Several regional and international NAFLD/NASH cohorts and biobanks have successfully advanced understanding of risk factors and biomarkers, though translating findings into widely effective treatments remains an ongoing challenge.

Eligibility criteria

Inclusion Criteria:

1. Participant must be ≥ 18 years of age at the time of signing the informed consent
2. Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
3. To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:

   1. Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
   2. Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
   3. Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:

      * Abdominal obesity: a waist circumference of more than 35 inches (\>89cm) for women and more than 40 inches (\>102 cm) for men;
      * High blood pressure of 130/80 mm Hg or higher. Normal blood pressure is defined as less than 130 mm Hg for systolic pressure, and less than 80 mm Hg for diastolic pressure
      * Impaired fasting blood glucose. This means a level equal to or greater than 100 mg/dL (\>5.6 mmol/L)
      * High triglyceride levels of more than 150 mg/dL (\> 1.7mmol/L).
      * Low HDL (good) cholesterol: less than 40 mg/dL (\< 1.04 mmol/L) for men and less than 50 mg/dL (\< 1.29 mmol/L) for women
4. alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine

Exclusion Criteria:

1. To have a diagnosis of type I diabetes mellitus
2. To have a concomitant liver disease
3. To take or have taken in the last 12 months before enrolment, on more than 50% of days, drugs that may cause liver steatosis (long-term high dose systemic corticosteroids (\> 20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens and valproic acid)
4. Pregnancy and breast feeding.

Where this trial is running

Lugano, Canton Ticino

• Fondazione Epatocentro Ticino — Lugano, Canton Ticino, Switzerland (Recruiting)

Study contacts

• Study coordinator: Andreas Cerny, Prof. Dr. med

Conditions NAFLD; MASH; NASH/MASH; NASH; Steatoepatitis