Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer (Paired Analysis of Sensitivity for Colorectal Cancer using COLVERA: PASCAL)

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Updated on 19 February 2024

Summary

The purpose of this study is to compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in subjects with colorectal cancer that have documented recurrence or no evidence of recurrence by CT.

Description

This is a single cohort observational, prospective comparison study where blood is collected for assay of methylated BCAT1 and IKZF1 DNA (?Colvera?), and for CEA assay, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC), and who are in remission and have had clinical follow-up (usually radiological imaging) as part of their surveillance program for recurrence. For each study subject, the Colvera and CEA test results will be judged as true or false with respect to the Reference Standard.

Details
Condition colorectal cancer
Age 18years - 100years
Clinical Study IdentifierTX9254
Last Modified on19 February 2024

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