Liver Disease
Conditions
Keywords
NAFLD, NASH, non-alcoholic steatohepatitis, fatty liver disease
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins Bloomberg School of Public Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Continuing participants: * Previously enrolled in the NAFLD Database study, PIVENS or TONIC trials * Age at least 18 years during the consent process * Willingness to continue to be followed for up to 4 years * Ability and willingness to give written, informed consent to be enrolled into Database 2 New participants: * Age at least 18 years during the consent process * Willingness to be followed for up to 4 years * Ability and willingness to give written, informed consent to be screened for and, if eligible, to be enrolled into the Database 2 study * Minimal or no alcohol use history consistent with NAFLD (see
Exclusion criteria
) * Collection of a standard of care 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver histology scores | varies | 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 PIVENS or TONIC trials) |
Countries
United States
Outcome results
None listed