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

NCT04371042 | Recruiting

• 1 other identifier: 2576
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD - Nonalcoholic Fatty Liver Disease; Diabetes; Obesity; Metabolic Syndrome; Cirrhosis; Liver Cancer; NASH - Nonalcoholic Steatohepatitis; HCC - Hepatocellular Carcinoma; Fatty Liver

Keywords

NAFLD; NASH; NON-ALCHOLIC; LIVER; CIRRHOSIS; HEPATOCELLULAR CARCINOMA

Outcome Measures

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)

  35 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under the care at Fondazione Policlinico Gemelli IRCCS Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Catholic University of Rome, Fondazione Policlinico Gemelli IRCCS

Roma, Rome/lazio/italy, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Clinical data will be collected in the electronic form at baseline and thereafter on an annual basis. In the prospective project, biological sample (DNA, RNA, sera or whole blood; urine, feces, bile and liver tissues) are collected, only on a voluntary basis, at the time of recruitment and follow-up and stored at the biobank facility XBIOGEM at Fondazione Policlinico Univ. A. Gemelli IRCCS in Rome

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Obesity; Metabolic Syndrome; Fibrosis; Liver Neoplasms; Carcinoma, Hepatocellular; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Pathologic Processes; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

LUCA MIELE, MD, PhD

CONTACT

+390631051; luca.miele@policlinicogemelli.it; luca.miele@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: May 1, 2020
• Study Start: September 1, 2019
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 1, 2020

Record last verified: 2020-01

Locations

IT (1)