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Colorectal Cancer Screening Validation Study (CRC screening)

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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
BiotechNiks / Molecular Medicine Research Institute
Information provided by:
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.

Condition or disease
Colorectal Cancer Screening

Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. - 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 ]

Secondary Outcome Measures :
  1. - 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
Rectal smears ("cytology brush") samples and RNA recovered from such materials.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720993

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
IntelliGeneScan, Inc.
BiotechNiks / Molecular Medicine Research Institute

Responsible Party: Lothar Wieczorek, PhD, Clinical and Regulatory Consultant, IntelliGeneScan, Inc.
ClinicalTrials.gov Identifier: NCT00720993     History of Changes
Other Study ID Numbers: IGS-08-001
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: February 2009

Keywords provided by IntelliGeneScan, Inc.:
Colorectal cancer screening
Gene expression

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases