Colvera for Detection of Disease Recurrence



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:February 1, 2018
End Date:August 2019
Contact:Missy Tuck, M.S.
Email:missy.tuck@clinicalgenomics.com
Phone:732-744-4869

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

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.

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.

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.
We found this trial at
12
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Patrick Boland, MD
Phone: 716-845-8309
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Belleville, New Jersey 07109
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cleveland, Ohio 44106
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Dover, Delaware 19901
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Evanston, Illinois 60201
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Metairie, Louisiana 70006
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Redondo Beach, California 90277
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