Actively Recruiting

Age: 18Years +
All Genders
NCT07051863

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Led by Fondazione Epatocentro Ticino · Updated on 2025-07-09

200

Participants Needed

1

Research Sites

384 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria. This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.

CONDITIONS

Official Title

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be 18 years of age or older at the time of signing the informed consent
  • Participant must be willing to sign the informed consent form and complete all study visits and procedures
  • Have a diagnosis of NAFLD, NASH, or MAFLD confirmed by either liver biopsy, liver imaging (ultrasound, CT scan, MRI, or CAP), or metabolic syndrome with liver fibrosis or cirrhosis without another diagnosis
  • Metabolic syndrome diagnosis includes one or more of: abdominal obesity (waist circumference >35 inches for women, >40 inches for men), high blood pressure (130/80 mm Hg or higher), impaired fasting blood glucose (≥100 mg/dL), high triglycerides (>150 mg/dL), or low HDL cholesterol (<40 mg/dL for men, <50 mg/dL for women)
  • Alcohol consumption less than 21 units per week for males or less than 14 units per week for females in the 6 months before enrollment
  • No history of excessive alcohol consumption in the 5 years before enrollment
Not Eligible

You will not qualify if you...

  • Diagnosis of type I diabetes mellitus
  • Presence of another liver disease
  • Use of drugs that may cause liver fat buildup in the last 12 months on more than half the days, including high-dose corticosteroids (>20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high-dose estrogens, or valproic acid
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Epatocentro Ticino

Lugano, Canton Ticino, Switzerland, 6900

Actively Recruiting

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Research Team

A

Andreas Cerny, Prof. Dr. med

CONTACT

M

Maurizia Bissig

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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