Official Title
Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"
Brief Title
Colvera for Detection of Disease Recurrence
Protocol ID
NCT03706235
Lead Sponsor
Clinical Genomics Pathology
Brief 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.
Study Period
-
Enrollment Count
488 participants
Eligibility Criteria
Inclusion Criteria:
1. Subject is 18 years or older, and capable and willing to provide informed consent.
2. Subject has undergone curative treatment for primary CRC of stages II and III
(AJCC).
3. Subject has no clinical evidence of disease (NED) (after initial treatment)
4. Subject has concluded course of initial treatment for primary CRC (i.e. end of
surgery, chemotherapy and/or radiotherapy)
5. Subject is willing/able to provide a blood sample
Exclusion Criteria:
1. Subject has evidence of residual disease.
2. Subject has other organ cancer at the time of recruitment.
3. Subject has prior history of recurrent CRC.
4. Subject has concurrent serious non-neoplastic illness that makes enrollment
impractical or clinically inappropriate.
5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or
between blood collection and radiological imaging.
Filters
Colorectal Adenocarcinoma
COMPLETED
ADULT
OLDER_ADULT