Colorectal Cancer Clinical Trial
Official title:
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
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. ;
Observational Model: Case-Only, Time Perspective: Prospective
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