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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

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.

Disqualifiers

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.

Trial population

Patients under the care at Fondazione Policlinico Gemelli IRCCS Hospital

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Registry creation

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

Time frame
35 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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