At a glance
ClinicalIndex Comparison Record- ✓Age 50 to 84 years inclusive
- ✓Average risk for colorectal cancer development
- ✓Able and willing to undergo screening colonoscopy within 90 days of enrollment
- ✓Able and willing to provide stool samples per written instructions
- ✕Colonoscopy within previous 9 years
- ✕Double-contrast barium enema, virtual colonoscopy, or flexible sigmoidoscopy within previous 5 years
- ✕Personal history of colorectal cancer or adenoma
- ✕History of aerodigestive tract cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
In Brief
An observational study for Colorectal Neoplasms and 3 related conditions. Completed, enrolled 12,776 participants across 184 sites in 2 countries.
Detailed 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.