PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Recruiting · NCT04371042 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
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.
Where it is running
1 location listed.
- Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS - Roma, Rome/lazio/italy, Italy