Colorectal Cancer Screening Validation Study (CRC screening)

IntelliGeneScan

Status: Unknown

Conditions: Colorectal Cancer Screening

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT00720993

IGS-08-001

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

165 participants in 2 patient groups

1

Description:

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

2

Description:

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