Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): mailing of FIT kit directly to patient; mailed invitation to pick up lab requisition and then kit; mailing completed kits in for processing; dropping completed kits at lab for processing
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.; 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.; Patients mails completed kit in for processing using postage-paid reply envelope provided.; Patient takes completed FIT in to lab patient service centre for processing.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: colorectal cancer; fecal immunochemical test; fecal occult blood test; screening