The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies and contemporaneous biosamples, and will also invite pediatric participants from the prior NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric participants during the enrollment period.
All the new pediatric participants will have had a liver biopsy within 120 days prior to enrollment coupled with contemporaneous biosamples within 90 days prior to enrollment and up to 90 days before or 4-90 days after the biopsy. We estimate that at least 50 of the continuing pediatric participants will be due for a standard of care liver biopsy at the time of their enrollment into the pediatric Database 2 study, and will, as a result, also have a liver biopsy and contemporaneous biosamples.
Study Type
OBSERVATIONAL
Enrollment
969
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Liver histology scores
Liver histology scores (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up, or liver biopsy obtained for the TONIC trial)
Time frame: varies
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Ann & Robert H. Lurie Children's Hospital of Chicago (NWU)
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
St. Louis University
St Louis, Missouri, United States
University at Buffalo-Women and Children's Hospital of Buffalo
Buffalo, New York, United States
Columbia University
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
...and 2 more locations