Colorectal Cancer Screening Validation Study (CRC screening)

April 22, 2009 updated by: IntelliGeneScan, Inc.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- 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
Mai 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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
Mai 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IntelliGeneScan, Inc.

Collaborators

BiotechNiks / Molecular Medicine Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

July 21, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGS-08-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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