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Clinical Trial Multi-analyte Blood Test (CLiMB)

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ClinicalTrials.gov Identifier: NCT03694600
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
Helio Genomics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Liver Cirrhosis Diagnostic Test: Multi-analyte blood Test

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Study Design
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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : February 1, 2023
Estimated Study Completion Date : June 30, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
men or women between 21-84
Multi-analyte blood test screening alone and as combination with multi-analyte Test and Ultrasound in subjects diagnosed with liver cirrhosis
 Diagnostic 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.


Outcome Measures
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Primary Outcome Measures :
  1. Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs Ultrasound [ Time Frame: 1 month ]
    The primary objective is to compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the multi-analyte blood Test for the detection of liver cancers within a high-risk population.


Secondary Outcome Measures :
  1. To compare the performance (sensitivity and specificity) of ultrasound alone to the multi-analyte blood Test alone for the detection of liver cancers. [ Time Frame: 1 month ]
    To compare the performance (sensitivity and specificity) of the multi-analyte blood Test alone to ultrasound alone for the detection of liver cancer.

  2. To compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the multi-analyte blood Test for the detection of liver cancer lesions that are ≤ 2cm in diameter. [ Time Frame: 1 month ]
    To compare the performance (sensitivity and specificity) of ultrasound alone to the combination of both ultrasound and the multi-analyte blood Test for the detection of liver cancer lesions that are ≤ 2cm in diameter.

  3. To compare the performance (sensitivity and specificity) of ultrasound alone to the multi-analyte Test alone for the detection of liver cancer lesions that are ≤ 2cm in diameter. [ Time Frame: 1 month ]
    To compare the performance (sensitivity and specificity) of ultrasound alone to the multi-analyte blood Test alone for the detection of liver cancer lesions that are ≤ 2cm in diameter.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694600


Locations
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Sponsors and Collaborators
Helio Genomics
Investigators
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Study Director: Taggart, PhD Helio Genomics
More Information
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Responsible Party: Helio Genomics
ClinicalTrials.gov Identifier: NCT03694600    
Other Study ID Numbers: LAM-2018-01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases