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The NAFLD Database 2 will recruit at least 1,500 new adult participants suspected or known to have NAFLD or nonalcoholic steatohepatitis (NASH)-related cirrhosis and will also invite adult participants from the prior NAFLD Database and related studies (PIVENS trial and TONIC trial) to enroll in the NAFLD Database 2. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.
To add to the existing NAFLD Database an additional 1,500 adult participants with a diagnosis of NAFLD, supported by a recent liver biopsy, with a broad range of severity. Core data collection will include clinical, demographic, laboratory, imaging, and histological features * To increase the population diversity of the NAFLD Database to provide greater representation of Hispanic, Native American, African American, and Asian patients among the new adult participants recruited into the NAFLD Database 2 * To expand the current specimen bank comprised of liver tissue, serum, plasma, and DNA obtained from new participants and continuing participants undergoing repeat liver biopsy with the specific goal of optimizing the collection of plasma or serum suitable for biomarker development studies by obtaining specimens in close temporal proximity to the performance of liver biopsy
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California, San Diego
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
Indiana University
Indianapolis, Indiana, United States
St. Louis University
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Start Date
December 2, 2009
Primary Completion Date
May 31, 2020
Completion Date
May 31, 2020
Last Updated
February 23, 2022
2,501
ACTUAL participants
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
NCT07480057
NCT07237750
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06181409