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 to ultrasound alone 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
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