Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Performance characteristics of the Septin 9 biomarker among patients who have a positive FIT result

Outcome Description:

Sensitivity, specificity, positive predictive value, and negative predictive value of Septin 9 (relative to colonoscopy) for detecting CRC in a sample of individuals with a positive test result for single-sample OC-Micro FIT using various thresholds for Septin 9 positivity.

Outcome Time Frame:

Participants are prospectively enrolled. Eligible participants will be asked to provide a blood sample at least 2 days prior to receiving a colonoscopy. The timeframe for participation will generally be within 3 months of receiving a positive FIT result.

Safety Issue:

No

Principal Investigator

Gloria Coronado, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kaiser Permanente, Center for Health Research NW

Authority:

United States: Institutional Review Board

Study ID:

Septin 9 Colorectal Biomarker

NCT ID:

NCT01574677

Start Date:

June 2012

Completion Date:

Related Keywords:

• Colorectal Cancer
• Colorectal cancer
• fecal immunochemical test
• Septin 9
• screening
• Colorectal Neoplasms