AGED Diagnostics Liver Disease Assessment (AGEDDX)

April 1, 2024 updated by: Active Genomes Expressed Diagnostics, Corp

AGED Diagnostics Epigenetic Modifications of Liver Disease Assessment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and separately conduct a comparative analysis of patient liver tissue and patient plasma samples to assess NASH encompassing NASH with mild fibrosis, NASH with significant fibrosis and NASH with advanced fibrosis. The purpose of each is to identify a set of markers that have biological relevance on the liver and then identify epigenetic biomarkers in plasma derived from liver tissue. Note: both a subset of NASH specific biomarkers and fibrosis specific biomarkers have been previously reported for technical feasibility.

Aim 2: Biomarker Validation, Targeted Epigenetic Sequencing Assessment 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. Conduct comparative analysis between various targeted sequencing and PCR based modalities. Candidate biomarker performance will be evaluated based on sensitivity, specificity, AUROC and reproducibility, among several other assessments.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant with liver biopsy over the past 1-2 years are permissible for study inclusion.
  • Participant is considered to be a "Healthy Subject" relative to any form of liver disease OR
  • Participant is suspected of having one of the following diagnoses: metabolic syndrome, NAFLD, fibrosis/cirrhosis, cardiovascular disease, chronic kidney disease.

Exclusion Criteria:

  • Participant is known to have HIV, Hepatitis B or Hepatitis C
  • Participant has any other known form of chronic liver disease (aside from NAFLD/liver fibrosis)
  • Participant has excess alcohol intake, excess alcohol is defined as participants that exceed an average 20g of alcohol daily for females (140g weekly intake) and average 30g of alcohol daily for males (210g weekly intake)
  • Participant has had a bone marrow transplant at any time
  • Participant is on anti-coagulation or anti-platelet therapy
  • Participant is known to be pregnant
  • Participant is unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Health controls
Diagnostic assessment
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
Other: NAFLD

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.
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)
Other: Liver Fibrosis

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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma
Time Frame: 6-9 months
Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and a separate assessment that can stage liver fibrosis.
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Validation, Targeted Epigenetic Sequencing Assessment
Time Frame: 6-9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Genomes Expressed Diagnostics, Corp

Collaborators

Walter Reed National Military Medical Center
Arizona Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7437787981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on AGED Multiple Target Assay in Healthy Controls

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe