Colorectal Cancer Screening Validation Study

NCT ID: NCT00720993

Last Updated: 2009-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Screening

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions.

No interventions assigned to this group

2

Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BiotechNiks / Molecular Medicine Research Institute

UNKNOWN

Sponsor Role collaborator

IntelliGeneScan, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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IntelliGeneScan, Inc.

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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IGS-08-001

Identifier Type: -

Identifier Source: org_study_id

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