AGED Diagnostics Liver Disease Assessment
Status unconfirmed · Early Phase 1
Conditions studied: NASH With Fibrosis, NAFLD, Healthy
In brief
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.
Key facts
- Study ID
- NCT06348563
- Run by
- Active Genomes Expressed Diagnostics, Corp
- People needed
- 400
- Starts
- 2024-05-15
- Expected to finish
- 2025-09-15
- Last updated by the study team
- 2024-04-04
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
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
Where it is running
- AGED Diagnostics — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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