Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C)
|ClinicalTrials.gov Identifier: NCT01397747|
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
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.
|Condition or disease|
|Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer|
|Study Type :||Observational|
|Actual Enrollment :||12776 participants|
|Official Title:||Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study|
|Study Start Date :||June 2011|
|Primary Completion Date :||February 2013|
|Study Completion Date :||May 2013|
Average risk patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.
- Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer. [ Time Frame: 90 Days ]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).
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397747
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|Principal Investigator:||Thomas Imperiale, MD||Principal Study Investigator|