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Colorectal Cancer Screening Validation Study (CRC screening)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
BiotechNiks / Molecular Medicine Research Institute
Information provided by:
IntelliGeneScan, Inc.
ClinicalTrials.gov Identifier:
NCT00720993
First received: July 21, 2008
Last updated: April 22, 2009
Last verified: February 2009

July 21, 2008
April 22, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00720993 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
165
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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00720993
IGS-08-001
No
Lothar Wieczorek, PhD, Clinical and Regulatory Consultant, IntelliGeneScan, Inc.
IntelliGeneScan, Inc.
BiotechNiks / Molecular Medicine Research Institute
Not Provided
IntelliGeneScan, Inc.
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP