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NCT00720993 Clinical Trial

Colorectal Cancer Screening Validation Study

Colorectal Cancer Screening Clinical Trial

— CRC screening  

Official title:
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00720993
Other study ID # IGS-08-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 21, 2008
Last updated April 22, 2009
Start date August 2008
Est. completion date May 2009

Study information
Verified date February 2009
Source IntelliGeneScan, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 165
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
IntelliGeneScan, Inc. BiotechNiks / Molecular Medicine Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary - 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 No
Secondary - 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 No
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