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.
Patient is between the ages of 18 and 75.
Patient understands and is willing to sign a written informed consent form (ICF).
Patient has been diagnosed with or is suspected of having MASLD, more specifically, either simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction and alcohol-associated liver disease (MetALD), or a confirmed or suspected diagnosis of liver fibrosis and are being evaluated for fibrosis stage
Patient has had or will have a diagnostic liver biopsy within 12 months (before or after) being enrolled in the study.
Patient is unable or unwilling to provide informed consent.
Patient has or has had any form of liver cancer.
Patient is known to have HIV, Hepatitis B or Hepatitis C.
Patient has had a liver transplant at any time.
The study will enroll \~425 adults with suspected metabolic dysfunction-associated steatotic liver disease (MASLD) who have undergone or are scheduled to undergo a liver biopsy as part of their routine clinical care. Participants will represent a range of disease severity, including simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis stages F0-F4. The study population will include approximately 100 participants with simple steatosis and 325 participants with MASH across varying stages of fibrosis. A subset may have metabolic dysfunction and alcohol-associated liver disease (MetALD). All participants will be independent of those enrolled in previous AGED Diagnostics studies.
Cohort
Prospective
Not listed
Diagnostic Accuracy of the Blood-Based MASH Prediction Model
The diagnostic performance of the investigational blood-based MASH prediction model will be evaluated by comparing predicted classifications of MASH and simple steatosis with liver biopsy findings. Performance will be assessed using overall diagnostic accuracy, sensitivity, specificity and area under the receiver operating characteristic curve (AUROC) in an independent validation cohort.
Diagnostic Accuracy of the Blood-Based Liver Fibrosis Prediction Model
The diagnostic performance of the investigational blood-based liver fibrosis prediction model will be evaluated by comparing predicted fibrosis stages with liver biopsy findings. Performance will be assessed using overall staging accuracy and the ability to distinguish minimal fibrosis (F0-F1), moderate fibrosis (F2), advanced fibrosis (F3) and cirrhosis (F4) in an independent validation cohort.
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