Clinical trial NCT01754896: Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
Official title: Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
fecal immunochemical test
fecal occult blood test
screening
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Cancer Care Ontario
First posted: 2012-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: FIT Kit uptake
timeFrame: September 2012 to April 2013
Secondary outcomes:
measure: Rejection rates
timeFrame: September 2012 to April 2013
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr. Jill Tinmouth
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Jill Tinmouth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Care Ontario
name: Linda Rabeneck, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Evaluative Studies (ICES)
name: Lawrence Paszat, MD, SM
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michaels Hospital
name: Nancy Baxter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Health
name: Edward Randall, PhD, DCC
role: PRINCIPAL_INVESTIGATOR
References: