Prospective NAFLD/NASH patient cohort and biobank

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fondazione Epatocentro Ticino
  Lugano, Canton Ticino, Switzerland Recruiting

Study contacts

• Study coordinator: Andreas Cerny, Prof. Dr. med
• Email: andreas.cerny@hin.ch
• Phone: 0041919106570

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.