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Clinical Trials in the USA / NCT03694600
Active, not recruiting Observational

Clinical Trial Multi-analyte Blood Test

NCT03694600 · tracked via the Priya Life Science USA tracker
Sponsor
Helio Genomics
Phase
Observational
Started
2019-02-04
Last updated
2026-07-10

Condition(s) studied

Liver Cirrhosis

Investigational drug(s) / intervention(s)

Multi-analyte blood Test

Multi-analyte blood Test: intended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens.

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
84 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
AZ Liver Health (Chandler) Chandler Arizona
AZ Liver Health (Glendale, Peoria) Peoria Arizona
AZ Liver Health (Tucson) Tucson Arizona
Banner University Hospital (University of Arizona Tucson) Tucson Arizona
Alliance Research Centers Irvine California
University of South California Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Stanford University Palo Alto California
University of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado
Covenant Metabolic LLC Fort Myers Florida
University of Florida Clinical and Translational Science Institute Gainesville Florida
University of Miami - Schiff Center for Liver Diseases Miami Florida
Gastroenterology Group of Naples Naples Florida
Covenant Metabolics LLC Sarasota Florida
Atlanta Gastroenterology Atlanta Georgia
Piedmont Research Institute Atlanta Georgia
Loyola University Medical Center Maywood Illinois
St Luke's Hospital of Kansas City Kansas City Kansas
University of Louisville Louisville Kentucky
Tulane University Health Sciences Center New Orleans Louisiana
Ochsner Clinic Foundation New Orleans Louisiana
Louisiana Research Center, LLC Shreveport Louisiana
Kansas City Research Institute (KCRI) Kansas City Missouri
PMG Research of Winston-Salem Winston-Salem North Carolina
University of Cincinnati College of Medicine Cincinnati Ohio
Gastro One in Memphis Memphis Tennessee
Quality Medical Nashville Tennessee
Liver Center of Texas Dallas Texas
Methodist Dallas Medical Center Dallas Texas
SouthTexas Research Institute Edinburg Texas
Texas Gastro Clinic El Paso Texas
Konkord Research Houston Texas
Texas Liver Institute - American Research Corp. San Antonio Texas
Impact Research Institute Waco Texas
Digestive & Liver Disease Specialists (DLDS) - Norfolk Norfolk Virginia
VA Richmond Richmond Virginia
Harborview Medical Center (University of Washington) Seattle Washington
Liver Institute Northwest Seattle Washington

More Helio Genomics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03694600 on ClinicalTrials.gov ↗ ← All trials in the USA