Colorectal Cancer Screening Validation Study

Altered Gene Expression in Colorectal Smears of Individuals With Colon Cancer

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00720993

Acronym

CRC screening

Enrollment

165

Registered

2008-07-23

Start date

2008-08-31

Completion date

2009-05-31

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

Colorectal cancer screening, Gene expression, RTPCR

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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	Mai 2009

Secondary

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	Mai 2009

Countries

United States

Outcome results