RecruitingNCT04371042

PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

5,000 participants

Start Date

Sep 1, 2019

Study Type

OBSERVATIONAL

Conditions

Liver Cancer Obesity Metabolic Syndrome Cirrhosis Diabetes HCC - Hepatocellular Carcinoma NAFLD (Nonalcoholic Fatty Liver Disease)NASH - Nonalcoholic Steatohepatitis Fatty Liver

Summary

The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and/or HCC-Hepatocellular carcinoma) and for comparative purpose a cohort of subjects with diabetes and/or obesity and/or other risk factors (i.e. psoriasis, IBD (inflammatory bowel disease), dyslipidemia) without NAFLD in order to have a clinical phenotypical characterization and the collection of biological specimens. We will collect clinical data, biological samples and imaging results in order to perform future cross-sectional studies and/or longitudinal studies for elucidating pathways of the disease and develop and validate biomarkers for diagnosis, prognosis and monitoring liver disease and comorbidities in order to contribute to precision medicine in this field.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study — not a treatment trial — that collects biological samples and health data from people with fatty liver disease (NAFLD/NASH) or related conditions. The goal is to better understand the disease using advanced molecular testing (called 'omics') to discover new ways to diagnose and treat it. **You may be eligible if...** - You are 18 or older - You have been diagnosed with fatty liver disease (NAFLD), including simple fatty liver, NASH, cirrhosis related to metabolic disease, or liver cancer linked to NAFLD - Your diagnosis was confirmed by liver biopsy, blood tests, or imaging - You drink alcohol only in moderate amounts (within recommended guidelines) - You have risk factors for fatty liver disease such as diabetes, obesity, or metabolic syndrome **You may NOT be eligible if...** - You drink alcohol heavily (above recommended weekly limits) - You have a history of Type 1 diabetes - You are unable or unwilling to give informed consent - You do not meet the inclusion criteria as judged by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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