Clinical Trial Multi-analyte Blood Test

NCT03694600 | Unknown FDA Device

• 1 other identifier: LAM-2018-01
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 38

Brief 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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound

  The primary objective is to compare the performance (sensitivity and specificity) of the multi-analyte blood test alone to ultrasound alone for the detection of liver cancers within a high-risk population.

  1 month

Secondary Outcomes (1)

• Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound for the detection of liver cancer lesions that are ≤ 4 cm in diameter.

  1 month

Study Arms (1)

men or women between 21-84

Multi-analyte blood test alone versus ultrasound in subjects diagnosed with liver cirrhosis

Diagnostic Test: Multi-analyte blood Test

Interventions

Multi-analyte blood Test DIAGNOSTIC_TEST

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

men or women between 21-84

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The maximum study duration for any given subject participating in the trial will be approximately 21 months (includes Initial Surveillance Visit and Follow-Up Visits at 6 months, 12 months and 18 months). No study-related lab assessments, imaging or procedures shall be required for any subject after the Study Duration Period. Subject Eligibility Screening Period: 14 days Study Duration Period: Up to 21 months (includes Initial Surveillance Visit for all subjects and up to three Follow-Up Visits ONLY for subjects with indeterminant findings by diagnostic imaging) The maximum observational window for any subject enrolled in the study is expected to be approximately 21 months (for subjects with indeterminant findings by diagnostic imaging).

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

Sponsors & Collaborators

• Helio Genomics: lead

Study Sites (38)

AZ Liver Health (Chandler)

Chandler, Arizona, 85224, United States

Location

AZ Liver Health (Glendale, Peoria)

Peoria, Arizona, 85381, United States

Location

AZ Liver Health (Tucson)

Tucson, Arizona, 85712, United States

Location

Banner University Hospital (University of Arizona Tucson)

Tucson, Arizona, 85724, United States

Location

Alliance Research Centers

Irvine, California, 92612, United States

Location

University of South California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Covenant Metabolic LLC

Fort Myers, Florida, 33012, United States

Location

University of Florida Clinical and Translational Science Institute

Gainesville, Florida, 32610, United States

Location

University of Miami - Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Covenant Metabolics LLC

Sarasota, Florida, 34240, United States

Location

Atlanta Gastroenterology

Atlanta, Georgia, 30308, United States

Location

Piedmont Research Institute

Atlanta, Georgia, 30309, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St Luke's Hospital of Kansas City

Kansas City, Kansas, 64111, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Kansas City Research Institute (KCRI)

Kansas City, Missouri, 64131, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45627, United States

Location

Gastro One in Memphis

Memphis, Tennessee, 38104, United States

Location

Quality Medical

Nashville, Tennessee, 37211, United States

Location

Liver Center of Texas

Dallas, Texas, 75234, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 79936, United States

Location

SouthTexas Research Institute

Edinburg, Texas, 78539, United States

Location

Texas Gastro Clinic

El Paso, Texas, 79936, United States

Location

Konkord Research

Houston, Texas, 77065, United States

Location

Texas Liver Institute - American Research Corp.

San Antonio, Texas, 78215, United States

Location

Impact Research Institute

Waco, Texas, 76710, United States

Location

Digestive & Liver Disease Specialists (DLDS) - Norfolk

Norfolk, Virginia, 23502, United States

Location

VA Richmond

Richmond, Virginia, 23249, United States

Location

Harborview Medical Center (University of Washington)

Seattle, Washington, 98104, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Taggart, PhD

  Helio Genomics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 3, 2018
• Study Start: February 4, 2019
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2023-09

Locations

US (38)