Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed with Colorectal Cancer
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- STATUS
- Not Recruiting
Summary
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. The primary objective is to compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in colorectal cancer subjects who are undergoing surveillance for recurrence.
Description
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. The primary objective is to compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in colorectal cancer subjects who are undergoing surveillance for recurrence.
Details
| Condition | colorectal cancer |
|---|---|
| Age | 100years or below |
| Clinical Study Identifier | TX8486 |
| Last Modified on | 19 February 2024 |
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