NCT04371042 PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
| NCT ID | NCT04371042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | NAFLD - Nonalcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2019-09-01 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04371042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NAFLD - Nonalcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04371042 currently recruiting?
Yes, NCT04371042 is actively recruiting participants. Contact the research team at luca.miele@policlinicogemelli.it; luca.miele@unicatt.it for enrollment information.
Where is the NCT04371042 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT04371042 clinical trial?
NCT04371042 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 5,000 participants.