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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are establishing an observational study to create a detailed group of people with Non-alcoholic Fatty Liver Disease (NAFLD) at various stages, from simple fat buildup in the liver to severe conditions like cirrhosis and liver cancer. The study also includes a comparison group of people with diabetes, obesity, or other risk factors but without NAFLD. The goal is to better understand the clinical features and collect biological samples to study the disease pathways and develop markers for diagnosis and monitoring, contributing to personalized medicine. The study will gather clinical details, biological specimens, and imaging results over time. This will support future research to clarify how NAFLD develops and progresses, and to create and test biomarkers that can predict disease outcomes and monitor liver health and related conditions. The research focuses on how NAFLD relates to other metabolic and inflammatory diseases and aims to improve health management strategies. Participants will provide data through medical evaluations and sample collections, which may include imaging and laboratory tests. Researchers will track these findings over extended periods to observe disease progression and associated health issues. The primary outcome is the creation of a comprehensive registry lasting 35 years, enabling long-term follow-up and analysis to support precision treatment and public health planning for NAFLD and its complications.
CONDITIONS
Brief 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 diagnosis of NAFLD, including simple steatosis, NASH, metabolic cirrhosis, or NAFLD-related hepatocellular carcinoma
- Diagnosis based on liver biopsy showing NAFLD or biochemical and/or imaging findings consistent with NAFLD
- Average alcohol consumption of 21 units/week or less for males, or 14 units/week or less for females, in the past 6 months
- Clearance of HCV infection with sustained virological response for more than 6 months
- Presence of risk factors such as diabetes, metabolic syndrome, obesity, or psoriasis with no fatty liver detected on ultrasound
You will not qualify if you...
- Refusal or inability to provide 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
- Diagnosis or history of Type 1 diabetes mellitus
- Patients not meeting inclusion criteria or deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 years
Participants are observed over time to collect data on the progression of non-alcoholic fatty liver disease and related conditions through routine assessments and sample collections.
Visits scheduled as per registry protocol over many years
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
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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