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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Active Genomes Expressed Diagnostics, Corp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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