Diagnostic Assay for Liver Disease
(AGEDDX Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Active Genomes Expressed Diagnostics, Corp

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

Participant with liver biopsy over the past 1-2 years are permissible for study inclusion

My liver is healthy and I have no liver diseases.

I may have a condition like metabolic syndrome, liver disease, heart disease, or kidney disease.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Participant is known to have HIV, Hepatitis B or Hepatitis C

Participant is known to be pregnant

+4 more

Participant Groups

The trial is testing the AGED Multiple Target Assay on different groups: those with fibrosis, NAFLD patients, and healthy controls. It aims to validate biomarkers that can distinguish between simple fat accumulation in the liver and NASH, and also stage fibrosis using blood samples.

3Treatment groups

Experimental Treatment

Group I: NAFLDExperimental Treatment1 Intervention

Diagnostic assessment. confirmation of diagnosis from liver biopsy is required. * NASH Diagnosis is on histological assessment from NASH CRN score: * NASH CRN score of ≤ 3 is classified as steatosis. * NASH CRN score of ≥ 5 is classified as NASH. * Participant samples can be subsequently diagnosed with CAP or MRI-PDFF to rule out NASH (or in rule in simple steatosis) but cannot be used to rule in NASH (as biopsy is required for confirmation). * All diagnostic criteria for participant at time of visit is requested.

Group II: Liver FibrosisExperimental Treatment1 Intervention

Diagnostic assessment, For fibrosis diagnosis and analysis, diagnostic tools can constitute zero or mild fibrosis (F0-F1), significant fibrosis (F2), and advanced fibrosis (F3-F4) in the presence or absence of NASH. * Participant samples can be diagnosed through non-invasive modalities such as but not limited to FIB4, ELF, PROC3, and/or imaging modalities such as but not limited to vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE), acoustic radiation force impulse (AFRI) or multiparameter imaging assessments. * All diagnostic criteria for participant at time of visit is requested.

Group III: Health controlsExperimental Treatment1 Intervention

Diagnostic assessment