AGED Diagnostics Liver Disease Assessment

This study is developing new blood tests to help diagnose liver conditions like NAFLD (Non-Alcoholic Fatty Liver Disease) and NASH (Non-Alcoholic Steatohepatitis) with fibrosis. Researchers are looking for specific markers in your blood that can show if you have these conditions and how severe they are. The study will analyze blood samples using the AGED Multiple Target Assay to find these markers in healthy people, those with NAFLD, and those with liver fibrosis. The goal is to create a reliable blood test that can tell the difference between these conditions and stage the fibrosis. You can join if you are between 18 and 65 years old and have had a liver biopsy in the past 1-2 years, or if you are considered healthy, or have conditions like metabolic syndrome, NAFLD, fibrosis/cirrhosis, cardiovascular disease, or chronic kidney disease. The study aims to enroll 400 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 400 participants to test new diagnostic methods for liver disease.
What's involved
The study involves collecting blood samples for analysis and comparing them with liver tissue samples. The primary endpoint assessment is measured at 6-9 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 6-9 months.

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NCT06348563

AGED Diagnostics Liver Disease Assessment

UNKNOWN
EARLY_PHASE1Ages 18–65InterventionalDiagnostic
Active Genomes Expressed Diagnostics, Corp
~400 participants
Updated 2024-04-04 on ClinicalTrials.gov
What's tested:AGED Multiple Target Assay in Healthy ControlsAGED Multiple Target Assay in NAFLD ParticipantsAGED Multiple Target Assay in Fibrosis Participants

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma
Measured over 6-9 months
NASH With Fibrosis
NAFLD
Healthy
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

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

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
  • Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma6-9 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.