AGED Diagnostics Liver Disease Assessment

Healthy Clinical Trial

— AGEDDX  

Official title:

AGED Diagnostics Epigenetic Modifications of Liver Disease Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348563
• Other study ID #: 7437787981
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: May 15, 2024
• Est. completion date: September 15, 2025

Study information

• Verified date: April 2024
• Source: Active Genomes Expressed Diagnostics, Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 15, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Liver Diseases
• NAFLD

Intervention

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
• 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)
• 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)

Locations

Country	Name	City	State
United States	AGED Diagnostics	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Active Genomes Expressed Diagnostics, Corp	Arizona Clinical Trials, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a separate assessment that can stage liver fibrosis.	6-9 months
Secondary	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 through multiple targeted sequencing and PCR based modalities.	6-9 months