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Spots Global Cancer Trial Database for Colvera for Detection of Disease Recurrence

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Trial Identification

Brief Title: Colvera for Detection of Disease Recurrence

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"

Study ID: NCT03706235

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Torrance Memorial Physician Network, Redondo Beach, California, United States

Bayhealth, Dover, Delaware, United States

Rush University Medical Center, Chicago, Illinois, United States

NorthShore Health System, Evanston, Illinois, United States

Indiana University, Indianapolis, Indiana, United States

Colon and Rectal Surgery Associates, Metairie, Louisiana, United States

Providence Hospital-Ascension Health, Novi, Michigan, United States

Virginia Piper Cancer Institute-Allina Health, Minneapolis, Minnesota, United States

Essex Oncology, Belleville, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

University Hospitals, Cleveland, Ohio, United States

Baylor College of Medicine, Houston, Texas, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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