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Clinical Trial for the IvyGene Liver Cancer Test (CLiMB)

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ClinicalTrials.gov Identifier: NCT03694600
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : October 4, 2018
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

Detailed Description:

This multi-site, prospective study is designed to compare the sensitivity and specificity of the IvyGene Dx Liver Cancer Test alone, ultrasound alone and the combination of the IvyGene Dx Liver Cancer Test and ultrasound for the detection of HCC within a population at high risk of HCC due to liver cirrhosis. Subjects will be enrolled until the pre-determined number of subjects are enrolled.

Subjects with a diagnosis of liver cirrhosis and who are currently recommended for HCC screening every 6 months by ultrasound will be enrolled during a routine HCC screening visit. Within the same clinical visit as the ultrasound, blood samples will be drawn for the IvyGene Dx Liver Cancer Test and for determining the concentration of additional blood analytes, such as serum AFP concentrations. Samples that are drawn for determining the concentration of serum AFP or other analytes will be submitted to the local clinical laboratory used by each site. The results will be recorded by use of the subject's Case Report Form. Samples for the IvyGene Dx Liver Cancer Test will be collected using the IvyGene Dx Collection Kit according to the instructions provided with each sample collection kit and shipped to a laboratory for processing and testing. The qualitative result of the IvyGene Dx Liver Cancer Test will be returned to the enrolling study investigator. Depending upon the results, a determination will be subsequently made as to whether a subject will undergo further diagnostic imaging. The anticipated study duration for most subjects will be approximately 1 month to complete one round of HCC screening by using the IvyGene Dx Liver Cancer Test and ultrasound, and if needed, diagnostic imaging. Subjects that receive an indeterminant (LI-RADS score of 3) indication by diagnostic imaging will be recommended for a second round of HCC screening and diagnostic imaging in 6 months. Therefore, the anticipated study duration for these subjects that are recommended for a second round of HCC screening will be approximately 6 months.


Study Type : Observational
Estimated Enrollment : 1578 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
Estimated Study Start Date : December 28, 2018
Estimated Primary Completion Date : March 28, 2020
Estimated Study Completion Date : April 28, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
men or women between 40-84
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. Compare performance, both sensitivity and specificity, of Ultrasound alone to the combination of Ultrasound and IvyGene Test for lesions less than or equal to 2cm. [ 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.

  2. Independent assessment of sensitivity and specificity for Ultrasound and IvyGene test [ 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 cancers.

  3. Independent assessment of sensitivity and specificity of Ultrasound alone and IvyGene alone for lesions less than or equal to 2cm. [ 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.

  4. IvyGene test performance alone achieves sensitivity and specificity of greater than or equal to 85% [ Time Frame: 1 month ]
    To determine if the IvyGeneTM Dx Liver Cancer Test alone achieves a sensitivity of ≥85% and a specificity of ≥85% for the detection of liver cancer lesions within a high-risk population.



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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be on study for a period of approximately 7 months (subjects receiving an indeterminate finding by diagnostic imaging, may be followed up to an additional 6 months) Screening: 14 days Enrollment: 7 months Follow-up: 6 months (indeterminate subjects only) The total duration of the study is expected to be 13 months (which includes final subject follow-up).

The time between subject enrollment and any study-related blood draws or imaging procedures will not exceed 3 months. However, subjects that received an indeterminate finding by diagnostic imaging may be followed for up to an additional 6 months.

Criteria

Inclusion Criteria:

  • • Subject is age 40 and to 84 (inclusive)

    • Subject is able to read, comprehend and sign the Informed Consent Document
    • Subject is willing and able to undergo liver cancer screening by ultrasound and the IvyGeneTM Dx Liver Cancer Test
    • Subject is able and willing to undergo diagnostic imaging by multiphasic MRI if required by the Study Protocol
    • Subject has been diagnosed with liver cirrhosis by one or more of the methods in the table below

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 LAM through a separate clinical protocol
    • Subject is unable or unwilling to submit blood samples for testing, undergo ultrasound or undergo diagnostic imaging by MRI as required for the Study Protocol

Responsible Party: Laboratory for Advanced Medicine, Indiana
ClinicalTrials.gov Identifier: NCT03694600     History of Changes
Other Study ID Numbers: LAM-2018-01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Liver Neoplasms
Liver Cirrhosis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics