Clinical Trial

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

Study acronym: PROMETEO
Recruiting
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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.
Trial Details
NCT Number NCT04371042
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions NAFLD - Nonalcoholic Fatty Liver Disease, Diabetes, Obesity, Metabolic Syndrome, Cirrhosis, Liver Cancer, NASH - Nonalcoholic Steatohepatitis, HCC - Hepatocellular Carcinoma +1 more
Enrollment 5,000 participants
Start Date 2019-09-01
Primary Completion 2035-12-31 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2020-05-01