NCT00720993|Unknown
Colorectal Cancer Screening Validation Study
CRC screening
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
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CRC screening
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
Sponsor study identifier
observational
165
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 21, 2008
Actual (reported)July 23, 2008
Actual (reported)August 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- 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
- 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
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.
Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.
Mayo Clinic
Rochester, Minnesota, 55905, United States
Rectal smears ("cytology brush") samples and RNA recovered from such materials.
First Submitted
July 21, 2008
First Posted
July 23, 2008
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 23, 2009
Record last verified: 2009-02
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Source: ClinicalTrials.gov.
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