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AGED Diagnostics Liver Disease Assessment
Sponsor: Active Genomes Expressed Diagnostics, Corp
Summary
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.
Official title: AGED Diagnostics Epigenetic Modifications of Liver Disease Assessment
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-05-15
Completion Date
2025-09-15
Last Updated
2024-04-04
Healthy Volunteers
Yes
Conditions
Interventions
AGED Multiple Target Assay in Healthy Controls
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to healthy controls
AGED Multiple Target Assay in NAFLD Participants
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to NAFLD participants (defined as simple steatosis through NASH)
AGED Multiple Target Assay in Fibrosis Participants
Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to liver fibrosis stage (F0-F4)
Locations (1)
AGED Diagnostics
Bethesda, Maryland, United States