The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay. Subjects will undergo colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and representative histopathology slides resulting from subsequent definitive surgery may be retrieved in order to be evaluated by central pathology to confirm diagnosis and staging.
Study Type
OBSERVATIONAL
Enrollment
12,776
Achieve Clinical Research
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
HealthCare Partners
Alhambra, California, United States
HealthCare Partners
Arcadia, California, United States
Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100\*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100\*(multitarget DNA or FIT negative test/negative colonoscopy).
Time frame: 90 Days
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Valley Gastro Consultants
Arcadia, California, United States
Desert Oasis Healthcare
Bermuda Dunes, California, United States
HealthCare Partners
Burbank, California, United States
REMEK Research
Chino, California, United States
Southern California Oncology
Downey, California, United States
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