NCT03706235

Colvera for Detection of Disease Recurrence

Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 488 (actual)
• Sponsor: Clinical Genomics Pathology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. 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.

Conditions

• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Blood draw (venipuncture)	Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-08-16
• Completion: 2020-04-29
• First posted: 2018-10-15
• Last updated: 2020-07-14

Locations

12 sites across 1 country: United States