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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 : August 13, 2019
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 at high risk for developing liver cancer due to liver cirrhosis and who are eligible for liver cancer screening as determined by the patient's physician will be invited to participate. Subjects will then read, understand and sign the Informed Consent Form and the Authorization for Medical Records Form. Participation will consist of providing blood samples for testing with the IvyGeneTM Dx Liver Cancer Test and other blood analytes, undergoing abdominal ultrasound, and multiphasic MRI once upon entering the study. In addition to ultrasound screening (consistent with the current standard of care), all subjects will also undergo diagnostic imaging by multiphasic MRI. To this end, upon entering the study, subjects will provide a blood sample for determining AFP concentration and a blood sample for the IvyGeneTM Dx Liver Cancer Test. AFP concentrations will be determined by the clinical laboratory routinely utilized by each site. For each subject upon enrollment, the following blood analytes will also be determined: creatinine, prothrombin time, bilirubin, blood platelet count, ALT, AST and ALP. The results of all clinical laboratory tests will be recorded by use of the subject's Case Report Form. Whole blood samples drawn for the IvyGeneTM Dx Liver Cancer Test will be collected (according to the instructions provided with each sample collection kit) by using the IvyGeneTM Sample Collection, Stabilization and Shipping Kit, and shipped to a central LAM laboratory for testing. Samples will be assayed by laboratory technicians blinded to the results of any other testing. Within the same clinical visit as the blood draws, subjects will undergo conventional ultrasound to examine the liver. Every subject will go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by LI-RADS score and the number and size of any malignant lesions identified will be recorded. The images of all MRI, CT, or ultrasound will be saved and uploaded for evaluation by a blinded, centralized team of radiologists to confirm diagnosis. Any biopsy results or surgical pathology results that are generated for study subjects as part of current clinical practice will also be recorded.

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.


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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 : April 28, 2020
Estimated Study Completion Date : May 28, 2020

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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 21 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 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, Bonacini cirrhosis discriminant score or Lok index), Ultrasound with or without Transient Elastography, Magnetic Resonance Elastography, Diagnostic imaging by CT, Diagnostic imaging by MRI, or Liver biopsy

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
  • Subject would not routinely be recommended for HCC screening
  • Subject received diagnostic imaging by multiphasic MRI or CT with contrast 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, 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         
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     History of Changes
Other Study ID Numbers: LAM-2018-01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
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
Liver Extracts
Hematinics