NCT04371042Recruiting
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Source: ClinicalTrials.gov · Last updated 1 May 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 23 Jan 2020
- Start date
- 1 Sept 2019
- Primary completion date
- 31 Dec 2035
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- NCT number
- NCT04371042
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Sept 2019 to the primary completion date, 31 Dec 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Refusal or inability (lack of capacity) to give informed consent.
- Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.