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NOT YET RECRUITING
NCT06348563
EARLY_PHASE1

AGED Diagnostics Liver Disease Assessment

Sponsor: Active Genomes Expressed Diagnostics, Corp

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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

DIAGNOSTIC_TEST

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)

DIAGNOSTIC_TEST

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