NCT01397747

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,776 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 50 Years – 84 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Neoplasms
• Digestive System Diseases
• Colonic Diseases
• Colorectal Cancer

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2011-07-20
• Last updated: 2015-12-03
• Results posted: 2015-12-03

Locations

184 sites across 2 countries: United States, Canada