Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: mailing of FIT kit directly to patient
* Other: mailed invitation to pick up lab requisition and then kit
* Other: mailing completed kits in for processing
* Other: dropping completed kits at lab for processing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mail-out/Mail-back<br>Mailing of FIT kit directly to patient. Mailing completed kits in for processing. | Other: mailing of FIT kit directly to patient<br>* Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.<br>Other: mailing completed kits in for processing<br>* Patients mails completed kit in for processing using postage-paid reply envelope provided.<br>|
| Experimental: Mail-out/Drop-off<br>Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing. | Other: mailing of FIT kit directly to patient<br>* Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.<br>Other: dropping completed kits at lab for processing<br>* Patient takes completed FIT in to lab patient service centre for processing.<br>|
| Experimental: Pick-up/Mail-back<br>Mailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing. | Other: mailed invitation to pick up lab requisition and then kit<br>* Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.<br>Other: mailing completed kits in for processing<br>* Patients mails completed kit in for processing using postage-paid reply envelope provided.<br>|
| Experimental: Pick-up/Drop-off<br>Mailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing. | Other: mailed invitation to pick up lab requisition and then kit<br>* Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.<br>Other: dropping completed kits at lab for processing<br>* Patient takes completed FIT in to lab patient service centre for processing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIT Kit uptake | Comparing FIT kit uptake by patients invited to complete fecal occult blood screening for colorectal cancer using a Fecal Immunochemical Test (FIT), and provided with different kit distribution and return methods. | September 2012 to April 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejection rates | Assessing the impact of pre-labeling of FIT Kit collection vials with patient name and date of birth, compared to allowing hand-written labeling, on rates of kit rejection at the lab. | September 2012 to April 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, fecal immunochemical test, fecal occult blood test, screening