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Diagnostic Assay for Liver Disease (AGEDDX Trial)

Phase < 1

Waitlist Available

Research Sponsored by Active Genomes Expressed Diagnostics, Corp

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to validate biomarkers that can differentiate between different liver conditions and assess the severity of fibrosis using blood samples. The researchers will verify their testing methods using whole genome sequencing on a larger sample

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves diagnostic assays rather than drug treatments, traditional side effects are not applicable. However, participants may experience discomfort or minor risks associated with blood drawing procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma

Secondary study objectives

Biomarker Validation, Targeted Epigenetic Sequencing Assessment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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