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Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test


N/A
49 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test


Inclusion Criteria:



- Aged 49-80

- Member of Kaiser Permanente Northwest or Southeast

- English or Spanish speaking

- Had a positive fecal screening (FIT) and has an active referral to colonoscopy

Exclusion Criteria:

- Having a personal history of colon cancer

- Having had a prior colonoscopy within 5 years

- Currently under hospice care

- Currently in a skilled nursing facility

- Currently being treated for active cancer (any type)

- Having ever had carcinoid tumor or full colectomy

- Having indicated a preference at enrollment into Kaiser health plan to not
participate in research

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

Name

Location

Kaiser Permanente NorthwestPortland, Oregon  97227
Kaiser Permanente GeorgiaAtlanta, Georgia  30300