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Clinical Trial Multi-analyte Blood Test
Recruiting
Trial ID: NCT03694600
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
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
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
Intervention(s):
diagnostic test: Multi-analyte blood Test
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305