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Recruiting NCT07051863

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Trial Parameters

Condition NAFLD
Sponsor Fondazione Epatocentro Ticino
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-19
Completion 2030-12

Brief Summary

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.

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

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