Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01754896
First received: December 18, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • FIT Kit uptake [ Time Frame: September 2012 to April 2013 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rejection rates [ Time Frame: September 2012 to April 2013 ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mail-out/Mail-back
Mailing of FIT kit directly to patient. Mailing completed kits in for processing.
Other: mailing of FIT kit directly to patient
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
Other: mailing completed kits in for processing
Patients mails completed kit in for processing using postage-paid reply envelope provided.
Experimental: Mail-out/Drop-off
Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing.
Other: mailing of FIT kit directly to patient
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
Other: dropping completed kits at lab for processing
Patient takes completed FIT in to lab patient service centre for processing.
Experimental: Pick-up/Mail-back
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
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.
Other: mailing completed kits in for processing
Patients mails completed kit in for processing using postage-paid reply envelope provided.
Experimental: Pick-up/Drop-off
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
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.
Other: dropping completed kits at lab for processing
Patient takes completed FIT in to lab patient service centre for processing.

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

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754896

Locations
Canada, Ontario
Dr. Jill Tinmouth
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Cancer Care Ontario
Investigators
Principal Investigator: Jill Tinmouth, MD, PhD Sunnybrook Research Institute
Principal Investigator: Linda Rabeneck, MD, MPH Cancer Care Ontario
Principal Investigator: Lawrence Paszat, MD, SM Institute for Clinical Evaluative Studies (ICES)
Principal Investigator: Nancy Baxter, MD, PhD St. Michaels Hospital
Principal Investigator: Edward Randall, PhD, DCC Eastern Health
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01754896     History of Changes
Other Study ID Numbers: 209-2011
Study First Received: December 18, 2012
Last Updated: January 9, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
colorectal cancer
fecal immunochemical test
fecal occult blood test
screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 26, 2014