Clinical Trial Multi-analyte Blood Test

Running, not enrolling

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT03694600

Run by

Helio Genomics

People needed

1900

Starts

2019-02-04

Expected to finish

2027-12-30

Last updated by the study team

2026-07-10

Who can join

Age: 21 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index > 0.5)
• 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)
• Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report)
• Liver biopsy (liver cirrhosis indicated on pathology report)

You may not qualify if…

• 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

Where it is running

• AZ Liver Health (Chandler) — Chandler, Arizona, United States
• AZ Liver Health (Glendale, Peoria) — Peoria, Arizona, United States
• AZ Liver Health (Tucson) — Tucson, Arizona, United States
• Banner University Hospital (University of Arizona Tucson) — Tucson, Arizona, United States
• Alliance Research Centers — Irvine, California, United States
• University of South California — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Covenant Metabolic LLC — Fort Myers, Florida, United States
• University of Florida Clinical and Translational Science Institute — Gainesville, Florida, United States
• University of Miami - Schiff Center for Liver Diseases — Miami, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Covenant Metabolics LLC — Sarasota, Florida, United States
• Atlanta Gastroenterology — Atlanta, Georgia, United States
• Piedmont Research Institute — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• St Luke's Hospital of Kansas City — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Kansas City Research Institute (KCRI) — Kansas City, Missouri, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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