Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 12
- 主要终点
- Sensitivity, specificity, positive predictive value and negative predictive value
研究概览
简要总结
To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.
详细描述
This is an observational, prospective comparison study, where blood is collected for assay of methylated BCAT1 and IKZF1 DNA and CEA, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC) and who are in remission and scheduled for follow-up radiological imaging as part of their surveillance program for recurrence. Participation is for one visit only as part of each subject's surveillance-monitoring schedule. Two K2-EDTA blood tubes and two PAXgene™ tubes will be collected Any evidence of methylated BCAT1 and/or IKZF1 DNA in blood represents a Colvera "positive" result. CEA levels of 5ug/L or higher will represent a "positive" result. Sensitivity and specificity of the Colvera and CEA test will be estimated and compared in a paired fashion in each case where recurrence status has been investigated and determined by the site clinical management team. Blood testing shall be performed and analyzed by qualified staff blinded to clinical status. This is a cross-sectional observational non-significant risk study, and test results will not be used for clinical management, i.e. there will be no interventions in subjects consenting to participate in this Research Study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years or older, and capable and willing to provide informed consent.
- •Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).
- •Subject has no clinical evidence of disease (NED) (after initial treatment)
- •Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)
- •Subject is willing/able to provide a blood sample
排除标准
- •Subject has evidence of residual disease.
- •Subject has other organ cancer at the time of recruitment.
- •Subject has prior history of recurrent CRC.
- •Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.
- •Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.
结局指标
主要结局
Sensitivity, specificity, positive predictive value and negative predictive value
时间窗: 1.5 years
on positive or negative Colvera and CEA test results
次要结局
未报告次要终点