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
  Purpose

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
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)
Groups/Cohorts
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.

  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720993

Locations
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.
ClinicalTrials.gov 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
RTPCR

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

ClinicalTrials.gov processed this record on September 22, 2014