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AGED Diagnostics Liver Disease Assessment

NCT06348563 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-04-04

No results posted yet for this study

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.

Conditions

  • NASH With Fibrosis
  • NAFLD
  • Healthy

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)

Sponsors & Collaborators

  • Arizona Clinical Trials

    collaborator UNKNOWN

  • Walter Reed National Military Medical Center

    collaborator FED

  • Active Genomes Expressed Diagnostics, Corp

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2025-05-15
Completion
2025-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06348563 on ClinicalTrials.gov