Colorectal Cancer Screening Validation Study (CRC screening)
|ClinicalTrials.gov Identifier: NCT00720993|
Recruitment Status : Unknown
Verified February 2009 by IntelliGeneScan, Inc..
Recruitment status was: Enrolling by invitation
First Posted : July 23, 2008
Last Update Posted : April 23, 2009
|Condition or disease|
|Colorectal Cancer Screening|
|Study Type :||Observational|
|Estimated Enrollment :||165 participants|
|Observational Model:||Case Control|
|Official Title:||Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2009|
Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions.
Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening.
- - 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 [ Time Frame: Mai 2009 ]
- - 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 [ Time Frame: Mai 2009 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720993
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|