Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

Prior to implementation of new colorectal cancer (CRC) screening technology (fecal immunochemical test - FIT) in Ontario, there is a need for a laboratory and field assessment to validate and optimize its use in the Ontario climate and conditions (e.g., large geographic area) and to determine whether adjustments to the current structure of the ColonCancerCheck (CCC) Program would be required.

This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a field assessment to evaluate the effect of different distribution and return methods and pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18 months to complete, with patients being recruited through family physicians in patient enrollment model (PEM) family practices across the province of Ontario.

This Clinical Trials registration relates to Phase 2 of the study.

In 2008 Ontario launched the ColonCancerCheck (CCC) Program, an organized colorectal cancer (CRC) screening program in which average risk patients are offered an at-home screening test and increased risk patients are offered colonoscopy directly through their family physician.

Currently, Ontario's CCC Program utilizes guaiac fecal occult blood testing (gFOBT) in persons at average risk of CRC. However, the program is currently considering a change to fecal immunochemical testing (FIT).

FIT, which comes in quantitative and qualitative formats, is superior to the gFOBT from a scientific perspective because it specifically detects human hemoglobin. gFOBT uses an indirect detection which depends on a peroxidase reaction not specific for human hemoglobin. FIT methodology is also both more convenient and superior from a participant perspective and multiple studies have demonstrated higher participation rates and improved detection of CRC precursors as well as invasive CRCs with FIT compared to gFOBT.

Organized CRC screening programs considering quantitative FIT face certain additional challenges, including uncertain stability over time and tolerance to variation in temperature following sample collection and prior to arrival in a testing laboratory. Prior to implementation of FIT in Ontario, there is a need for a laboratory and field assessment to validate and optimize its use in the Ontario climate and conditions (e.g., large geographic area) and to determine whether adjustments to the current structure of the CCC Program would be required.

This study consists of 2 phases. Phase 1, laboratory testing, assesses 2 quantitative and 3 qualitative FIT kits to evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a field assessment to evaluate the effect of different distribution and return methods and pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18 months to complete, with patients being recruited through family physicians in patient enrollment model (PEM) family practices across the province of Ontario. Data collection will take place for 6 months, starting on the day that screening kits and/or invitation letters are mailed to patients.

This Clinical Trials registration relates to Phase 2 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Physician in Ontario with a patient enrollment model
* patient: 50-74, Ontario resident, enrolled with physician

Exclusion Criteria:

* patient: no personal or first degree relative family history of CRC, no FOBT within prior 5 years, colonoscopy within past 10 years, FOBT within past 2 years