This study is currently not recruiting participants.

Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed with Colorectal Cancer

  • STATUS
    Not Recruiting
Updated on 19 February 2024

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 IdentifierTX8486
Last Modified on19 February 2024

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