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AGEDDXAGED Diagnostics Epigenetic Modifications of Liver Disease Assessment

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What is being tested

AGED Multiple Target Assay in Healthy Controls

+ AGED Multiple Target Assay in NAFLD Participants

+ AGED Multiple Target Assay in Fibrosis Participants

Diagnostic Test
Who is being recruted

Digestive System Diseases+1

+ Fatty Liver

+ Liver Diseases

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorActive Genomes Expressed Diagnostics, Corp
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 15, 2024

Actual date on which the first participant was enrolled.

This study focuses on improving the diagnosis of liver diseases, specifically targeting conditions like steatosis and non-alcoholic steatohepatitis (NASH). Researchers aim to identify specific biomarkers that can help distinguish between these conditions, which include varying levels of fibrosis in the liver. By looking at both liver tissue and blood plasma from patients, the study seeks to find reliable markers that reflect liver health and disease progression. This is important because better diagnostic tools can lead to more accurate and earlier detection of liver diseases, potentially improving treatment outcomes for affected individuals. Participants in the study will undergo procedures to collect liver tissue and blood plasma samples. These samples will then be analyzed using a technique called whole genome bisulfite sequencing to identify potential biomarkers. The study will further evaluate the identified biomarkers using targeted sequencing and PCR methods. Researchers will assess the performance of these biomarkers based on their accuracy in detecting liver conditions. The study aims to ensure that the markers are sensitive and specific, meaning they can accurately identify the presence of liver disease without giving false results. This research could lead to the development of a simple blood test to diagnose liver diseases more effectively.

Official TitleAGED Diagnostics Epigenetic Modifications of Liver Disease Assessment
NCT06348563
Principal SponsorActive Genomes Expressed Diagnostics, Corp
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFatty LiverLiver DiseasesNon-alcoholic Fatty Liver Disease

Criteria

3 inclusion criteria required to participate
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.

7 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Diagnostic assessment

Group II

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 III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

AGED Diagnostics

Bethesda, United StatesOpen AGED Diagnostics in Google Maps
Recruiting soonOne Study Center
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