Clinical Trial for the IvyGene Liver Cancer Test

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

December 28, 2018

预计主要完成日期

March 28, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^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.

描述性信息

简略标题 ^ICMJE

Clinical Trial for the IvyGene Liver Cancer Test

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^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.

研究工具

: 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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

1578

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 28, 2020

预计主要完成日期

March 28, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^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

性别

参与研究的性别:

All

年龄

最小年龄：40 Years ，最大年龄：84 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Laboratory for Advanced Medicine, Indiana

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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