Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2
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.
• Continuing participants:
• Previously enrolled in the NAFLD Database study or TONIC trial
• Age at least 2 years and not older than 17 years during the consent process
• Willingness to continue to be followed for up to 4 years
• Ability and willingness to give written, informed parental consent and child assent, per local IRB guidelines, to be enrolled into the pediatric Database 2 study
• New participants:
• Age at least 2 years of age and not older than 17 years during the consent process
• Willingness to be followed for up to 4 years
• Ability and willingness to give written, informed parent consent and child assent to be enrolled into the pediatric Database 2 study
• Minimal or no alcohol use history consistent with NAFLD
• Having undergone a liver biopsy that is obtained within 120 days of enrollment
• Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy