Colorectal Cancer Screening Validation Study (CRC screening)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
BiotechNiks / Molecular Medicine Research Institute
Information provided by:
IntelliGeneScan, Inc.

July 21, 2008
July 23, 2008
April 23, 2009
August 2008
May 2009   (Final data collection date for primary outcome measure)
- 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 ]
Not Provided
Complete list of historical versions of study NCT00720993 on Archive Site
- 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 ]
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Colorectal Cancer Screening Validation Study
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
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.
Not Provided
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Rectal smears ("cytology brush") samples and RNA recovered from such materials.
Probability Sample
Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.
Colorectal Cancer Screening
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  • 1
    Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions.
  • 2
    Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Lothar Wieczorek, PhD, Clinical and Regulatory Consultant, IntelliGeneScan, Inc.
IntelliGeneScan, Inc.
BiotechNiks / Molecular Medicine Research Institute
Not Provided
IntelliGeneScan, Inc.
February 2009