Colorectal Cancer Screening Validation Study (CRC screening)

This study is enrolling participants by invitation only.
BiotechNiks / Molecular Medicine Research Institute
Information provided by:
IntelliGeneScan, Inc. Identifier:
First received: July 21, 2008
Last updated: April 22, 2009
Last verified: February 2009

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.

Colorectal Cancer Screening

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer

Resource links provided by NLM:

Further study details as provided by IntelliGeneScan, Inc.:

Primary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Rectal smears ("cytology brush") samples and RNA recovered from such materials.

Estimated Enrollment: 165
Study Start Date: August 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00720993

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

No publications provided

Responsible Party: Lothar Wieczorek, PhD, Clinical and Regulatory Consultant, IntelliGeneScan, Inc. Identifier: NCT00720993     History of Changes
Other Study ID Numbers: IGS-08-001
Study First Received: July 21, 2008
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board

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 processed this record on April 17, 2014