Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,900
- 试验地点
- 70
- 主要终点
- Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound
研究概览
简要总结
This is a clinical trial designed to evaluate the performance of a multi-analyte blood test alone to ultrasound alone for the detection of HCC within a population that is at high risk for HCC due to liver cirrhosis.
详细描述
This multi-site, prospective study is designed to compare the sensitivity and specificity of a multi-analyte blood test alone to ultrasound alone 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 HCC due to liver cirrhosis and who are eligible for liver cancer surveillance as determined by the patient's physician and who meet all inclusion and exclusion eligibility criteria as described in this protocol, will be invited to participate in this study. Subjects will then read, understand and sign the Informed Consent Form and the HIPAA Authorization Agreement for Medical Records Form.
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 multi-analyte blood test will be collected (according to the instructions provided with each sample collection kit) by using the multi-analyte 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 (when possible), subjects will undergo conventional ultrasound to examine the liver. Every subject will then 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.
Study procedures will consist of conventional ultrasound to examine the liver, providing blood samples for testing with the multi-analyte blood test and other conventional blood analytes, and diagnostic imaging by multiphasic MRI.
Upon enrolling in the study, subjects will commence the Initial Surveillance Visit (t=0 months). During the Initial Surveillance Visit, all enrolled subjects will undergo ultrasound to examine the liver and provide blood samples for the multi-analyte blood test and for determining conventional blood analytes. Every subject will then go on to diagnostic imaging by multiphasic MRI. The results of diagnostic imaging will primarily be scored by a Liver Reporting and Data System (LI-RADS) score. The data of all diagnostic imaging by MRI will be saved and uploaded for evaluation by a blinded, centralized team of radiologists, which will be used as the basis of the clinical truth for all subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 multi-analyte blood 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:
- •Clinical diagnosis by blood analytes (APRI ≥ 1.5 or Bonacini cirrhosis discriminant score ≥ 8 or Lok index > 0.5)
- •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)
- •Diagnostic imaging by CT or MRI (liver cirrhosis indicated on radiology report)
- •Liver biopsy (liver cirrhosis indicated on pathology report)
排除标准
- •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
结局指标
主要结局
Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound
时间窗: 1 month
The primary objective is to compare the performance (sensitivity and specificity) of the multi-analyte blood test alone to ultrasound alone for the detection of liver cancers within a high-risk population.
次要结局
- Independent performance measure of sensitivity and specificity of a multi-analyte blood test vs ultrasound for the detection of liver cancer lesions that are ≤ 4 cm in diameter.(1 month)