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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD | The primary objective of this project is to establish a unified cohort for retrospective and prospective highquality 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. | 7 years |
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Inclusion Criteria:
Participant must be ≥ 18 years of age at the time of signing the informed consent
Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:
Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:
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:
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Patient wiht diagnosis of NAFLD/NASH/MAFLD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Cerny, Prof. Dr. med | Contact | 0041919106570 | andreas.cerny@hin.ch | |
| Maurizia Bissig | Contact | maurizia.bissig@hin.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Epatocentro Ticino | Recruiting | Lugano | Canton Ticino | 6900 | Switzerland |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Serum, whole blood sample, citrate sample, Paxgene blood RNA, fecal samples, urine samples, fragments of liver biopsy specimens