AGED Diagnostics Liver Disease Assessment

NCT06348563 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 7437787981
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NASH With Fibrosis; NAFLD; Healthy

Outcome Measures

Primary Outcomes (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 a separate assessment that can stage liver fibrosis.

  6-9 months

Secondary Outcomes (1)

• Biomarker Validation, Targeted Epigenetic Sequencing Assessment

  6-9 months

Study Arms (3)

Health controls

OTHER

Diagnostic assessment

Diagnostic Test: AGED Multiple Target Assay in Healthy Controls

NAFLD

OTHER

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

Liver Fibrosis

OTHER

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

Interventions

AGED Multiple Target Assay in Healthy Controls DIAGNOSTIC_TEST

Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to healthy controls

Health controls

AGED Multiple Target Assay in NAFLD Participants DIAGNOSTIC_TEST

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)

NAFLD

AGED Multiple Target Assay in Fibrosis Participants DIAGNOSTIC_TEST

Analysis of blood based cfDNA/cfRNA biomarkers found at defined concentrations in participant samples that correlates to liver fibrosis stage (F0-F4)

Liver Fibrosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Active Genomes Expressed Diagnostics, Corp: lead
• Arizona Clinical Trials: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

AGED Diagnostics

Bethesda, Maryland, 20002, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 4, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (1)