Actively Recruiting
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2020-05-01
5000
Participants Needed
1
Research Sites
852 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical evidence of NAFLD including simple steatosis, NASH, metabolic cirrhosis, or NAFLD-related HCC
- Liver biopsy showing NAFLD or biochemical and/or imaging findings consistent with NAFLD
- Average alcohol consumption of 21 units/week or less for males and 14 units/week or less for females in the past 6 months
- Clearance of hepatitis C virus infection with sustained virological response for more than 6 months
- Presence of risk factors like diabetes, metabolic syndrome, obesity, or psoriasis without fatty liver seen on ultrasound
You will not qualify if you...
- Refusal or inability to give informed consent
- Average alcohol intake exceeding 21 units/week for males or 14 units/week for females in the past 6 months or history of sustained excessive alcohol use in the past 5 years
- History or current diagnosis of Type 1 diabetes mellitus
- Not meeting inclusion criteria or judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS
Roma, Rome/lazio/italy, Italy, 00168
Actively Recruiting
Research Team
L
LUCA MIELE, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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