Diagnostic Assay for Liver Disease
(AGEDDX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-coagulation or anti-platelet therapy.
Is the Diagnostic Assay for Liver Disease safe for humans?
The research does not provide specific safety data for the Diagnostic Assay for Liver Disease or its other names, but it highlights that liver function tends to be well maintained in healthy elderly individuals, suggesting that diagnostic procedures are generally safe. However, age-related changes in liver function can increase vulnerability to liver injury, so individual evaluation is important.12345
Are You a Good Fit for This Trial?
This trial is for people with liver disease, specifically those with non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), as well as healthy individuals. Participants will be involved in testing to help develop new ways to identify and differentiate between types of liver conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Test Method Verification
Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identify candidate biomarkers that can discriminate between steatosis and NASH, and stage liver fibrosis.
Biomarker Validation
Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma through multiple targeted sequencing and PCR based modalities.
Follow-up
Participants are monitored for safety and effectiveness after biomarker validation
What Are the Treatments Tested in This Trial?
Interventions
- AGED Diagnostics Liver Disease Assessment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Active Genomes Expressed Diagnostics, Corp
Lead Sponsor
Walter Reed National Military Medical Center
Collaborator
Arizona Clinical Trials
Collaborator