Colorectal Cancer Screening Validation Study
- Conditions
- Colorectal Cancer Screening
- Registration Number
- NCT00720993
- Lead Sponsor
- IntelliGeneScan, Inc.
- Brief Summary
The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
- willing to provide informed consent
- greater than or equal to 50 years of age
- patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
- subject is willing to provide colorectal mucosal sample for gene expression testing
Exclusion Criteria
- recent radiation or treatment for gynecologic, prostate or rectal cancer
- recent surgery for anal rectal disease
- polys, family or self history of cancer (control group only)
- GI disease
- any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data Mai 2009
- Secondary Outcome Measures
Name Time Method - To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates Mai 2009
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States