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Clinical Trial for the IvyGene Liver Cancer Test (CLiMB)

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ClinicalTrials.gov Identifier: NCT03694600
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Laboratory for Advanced Medicine, Indiana

Brief Summary:
This is a clinical trial designed to evaluate the performance of the IvyGene Dx Liver Cancer Test alone, ultrasound alone and the combination of both the IvyGene Dx Liver Cancer 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: IvyGene DX Liver Cancer Test

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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
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : May 28, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
men or women between 21-84
IvyGene DX Liver Cancer Test screening alone and as combination with IvyGene DX Liver Cancer Test and Ultrasound in subjects diagnosed with liver cirrhosis
Diagnostic Test: IvyGene DX Liver Cancer Test
intended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens.




Primary Outcome Measures :
  1. Independent performance measure of sensitivity and specificity of IvyGene 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 IvyGeneTM Dx Liver Cancer 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 IvyGeneTM Dx Liver Cancer Test alone for the detection of liver cancers. [ Time Frame: 1 month ]
    To compare the performance (sensitivity and specificity) of the IvyGeneTM Dx Liver Cancer 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 IvyGeneTM Dx Liver Cancer 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 IvyGeneTM Dx Liver Cancer 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 IvyGeneTM Dx Liver Cancer 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 IvyGeneTM Dx Liver Cancer Test alone for the detection of liver cancer lesions that are ≤ 2cm in diameter.



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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 IvyGene® Dx Liver Cancer 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

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


Contacts
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Contact: Alamdar Rizvi, MS 6308578049 ext 6308578049 alamdar.rizvi@lamoncogroup.com
Contact: David Taggart, PhD 6308578049 ext 6308578049 david.taggart@lamoncogroup.com

Locations
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United States, California
Alliance Research Centers Recruiting
Irvine, California, United States, 92612
Contact: Nicole Skvarna         
Principal Investigator: Kenneth Deck, MD         
United States, Florida
Gastroenterology Group of Naples Recruiting
Naples, Florida, United States, 34102
Contact: Paula Allain         
Principal Investigator: Raymond Phillips, MD         
United States, Missouri
Kansas City Research Institute (KCRI) Recruiting
Kansas City, Missouri, United States, 64131
Contact: Christy Altman         
Principal Investigator: Bradley Freilich, MD         
United States, Tennessee
Quality Medical Recruiting
Nashville, Tennessee, United States, 37211
Contact: Christy Swope         
Principal Investigator: Robert Herring, MD         
United States, Texas
Liver Center of Texas Recruiting
Dallas, Texas, United States, 75234
Contact: Abdullah Mubarak, MD         
Contact: Khadija Shoaib, PhD         
Principal Investigator: Abdullah Mubarak, MD         
Texas Liver Institute - American Research Corp. Recruiting
San Antonio, Texas, United States, 78215
Contact: Rodney Ray         
Principal Investigator: Eric Lawitz, MD         
United States, Virginia
Digestive & Liver Disease Specialists (DLDS) - Norfolk Recruiting
Norfolk, Virginia, United States, 23502
Contact: Aricka Fayton         
Principal Investigator: John Smith, MD         
Sponsors and Collaborators
Laboratory for Advanced Medicine, Indiana
Investigators
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Study Director: Alamdar Rizvi, MS Laboratory for Advanced Medicine
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Responsible Party: Laboratory for Advanced Medicine, Indiana
ClinicalTrials.gov Identifier: NCT03694600    
Other Study ID Numbers: LAM-2018-01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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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 Neoplasms
Liver Cirrhosis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases