AGED Diagnostics Clinical Validation Study

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Active Genomes Expressed Diagnostics, Corp
Study ID
NCT07867574
Status
Not Yet Recruiting

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Conditions

  • Fibrosis and Cirrhosis of Liver
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • MetALD

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the assessment of liver fibrosis (scarring). MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) that can lead to advanced liver disease, cirrhosis and liver-related complications. This prospective, observational study will enroll approximately 400-500 patients with suspected MASLD who are undergoing liver biopsy as part of their clinical care. Researchers will collect blood samples and relevant medical information from participants at multiple clinical sites. The blood samples will be analyzed using advanced DNA sequencing technology to measure DNA methylation, a biological marker that may provide information about liver health. The study will evaluate how accurately the investigational blood tests distinguish MASH from simple steatosis (fat accumulation in the liver without MASH) and identify different stages of liver fibrosis. Blood test results will be compared with liver biopsy findings. The results will be used to select and validate the most accurate prediction models for future clinical utility studies. The long-term goal is to develop noninvasive blood tests that may help healthcare providers identify patients with MASH and liver fibrosis earlier and guide appropriate clinical care.

Key Dates

First listed
Oct 9, 2026
Start date
Oct 15, 2026
Status verified
Oct 2026
Primary completion
Dec 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Simple Steatosis
    * NASH CRN ≤3 * Fibrosis stage F0-F1
  • Arm: MASH - Group 1
    * NASH CRN 4-8 * Fibrosis stage F0-F1
  • Arm: MASH - Group 2
    * NASH CRN 4-8 * Fibrosis stage F2
  • Arm: MASH - Group 3
    * NASH CRN 4-8 * Fibrosis stage F3
  • Arm: MASH - Group 4
    * NASH CRN 4-8 * Fibrosis stage F4 (cirrhosis)

Primary Outcome Measure

Diagnostic Accuracy of the Blood-Based MASH Prediction Model [ Time Frame: From blood sample collection through completion of the independent validation analysis (approximately 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AGED Diagnostics Central LabBethesdaMaryland20852
Jasmine Kirksey
[email protected]
617-777-7971

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By research site
AGED Diagnostics Central Lab· Bethesda, MD

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