Diagnostic Assay for Liver Disease

(AGEDDX Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Active Genomes Expressed Diagnostics, Corp

Must not be taking: Anti-coagulation, Anti-platelet

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

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. ^{1 2 3 4 5}

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

6-9 months

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.

6-9 months

Follow-up

Participants are monitored for safety and effectiveness after biomarker validation

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGED Diagnostics Liver Disease Assessment

Trial Overview 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.

How Is the Trial Designed?

Group I: NAFLD Experimental Treatment 1 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 Fibrosis Experimental Treatment 1 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 controls Experimental Treatment 1 Intervention

Diagnostic assessment

Who Is Running the Clinical Trial?

Active Genomes Expressed Diagnostics, Corp

Lead Sponsor

Trials

1

Recruited

400+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Arizona Clinical Trials

Collaborator

Trials

1

Recruited

400+

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Characteristics of liver diseases in the elderly: a review. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnostic and prognostic performance of the SAFE score in non-alcoholic fatty liver disease. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Liver dysfunction in geriatric patients]. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Liver diseases in the elderly. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Early detection of alcohol-related liver disease]. [2021]