Clinical Trial Multi-analyte Blood Test
Trial ID or NCT#
NCT03694600
Status
RECRUITING
Purpose
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone, ultrasound alone and the combination of both the multi-analyte blood test and ultrasound for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
Official Title
Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
Eligibility Criteria
Ages Eligible for Study: 21 Years to 84 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- - Subject is age 21 to 84 (inclusive) - Subject is able to read, comprehend and sign the Informed Consent Document - Subject is willing and able to undergo liver cancer surveillance by ultrasound and the multi-analyte blood Test - Subject is able and willing to undergo diagnostic imaging by multiphasic MRI with contrast according to the Study Protocol - Subject has been diagnosed with liver cirrhosis by one or more of the following methods: 1. Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index > 0.5) 2. Ultrasound and Elastography > 12.5 kPa (Vibration-controlled transient elastography, Point shear wave elastography, Two-dimensional shear wave ultrasound and transient elastography or Magnetic Resonance Elastography) 3. Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report) 4. Liver biopsy (liver cirrhosis indicated on pathology report)
Exclusion Criteria:
- - The study investigator deems the subject's participation to be unsafe due to an underlying medical condition - Subject has previously been diagnosed with a primary liver cancer or a non-liver cancer that has metastasized - Subject has previously submitted a blood sample to Helio Health (HELIO) through a separate clinical protocol - Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by multiphasic MRI with contrast as required for the Study Protocol - Subject has any internal metallic device or fragment, including but not limited to: A pacemaker, artificial joint or valve, surgical clips, pins, plates, screws, wire mesh or shrapnel - It is unsafe for the subject to receive an MRI contrast dye due to pregnancy or severe kidney disease - Subject would not routinely be recommended for HCC surveillance - Subject received an abdominal ultrasound or diagnostic imaging by MRI or CT to image the liver within the past 5 months
Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist,
Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
View on ClinicalTrials.gov
