Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT04371042

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionNAFLD - Nonalcoholic Fatty Liver Disease, Diabetes, Obesity, Metabolic Syndrome, Cirrhosis, Liver Cancer, NASH - Nonalcoholic Steatohepatitis, HCC - Hepatocellular Carcinoma, Fatty Liver

Full registry criteria

Inclusion Criteria: * Age ≥18 years * Clinical phenotype of NAFLD (simple steatosis, NASH, metabolic cirrhosis, NAFLD-HCC) based on any of: * Liver biopsy providing histological evidence of NAFLD or, * Biochemical and/or radiological findings consistent with NAFLD * Average alcohol consumption ≤21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years. * Clearance of HCV infection with new DAAs drugs with a SVR (sustained virological response) period \> 6 months * Presence of risk factors for NAFLD (i.e. diabetes, metabolic syndrome, obesity, psoriasis) and absence of fatty liver at US Exclusion Criteria: * Refusal or inability (lack of capacity) to give informed consent. * Average alcohol ingestion \>21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years. * History or presence of Type 1 diabetes mellitus. * Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Registry creation35 years

Set up an observational cohort with NAFLD at different stage of disease (from simple steatosis to cirrhosis and/or HCC)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS🇮🇹 Roma, Rome/lazio/italy, Italy

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Luca Miele, MD PhDContact