Clinical Trial for the IvyGene Liver Cancer Test

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

December 28, 2018

Estimated Primary Completion Date

March 28, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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.
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.
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.

Descriptive Information

Brief Title ^ICMJE

Clinical Trial for the IvyGene Liver Cancer Test

Official Title ^ICMJE

Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study

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.

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1578

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 28, 2020

Estimated Primary Completion Date

March 28, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Laboratory for Advanced Medicine, Indiana

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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