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Trial record 41 of 318 for:    colon cancer | ( Map: Canada )

Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

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ClinicalTrials.gov Identifier: NCT01754896
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date December 23, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
FIT Kit uptake [ Time Frame: September 2012 to April 2013 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01754896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Rejection rates [ Time Frame: September 2012 to April 2013 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
Official Title  ICMJE Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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: 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.
  • Other: dropping completed kits at lab for processing
    Patient takes completed FIT in to lab patient service centre for processing.
Study Arms  ICMJE
  • Experimental: Mail-out/Mail-back
    Mailing of FIT kit directly to patient. Mailing completed kits in for processing.
    Interventions:
    • Other: mailing of FIT kit directly to patient
    • Other: mailing completed kits in for processing
  • Experimental: Mail-out/Drop-off
    Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing.
    Interventions:
    • Other: mailing of FIT kit directly to patient
    • Other: dropping completed kits at lab for processing
  • Experimental: Pick-up/Mail-back
    Mailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing.
    Interventions:
    • Other: mailed invitation to pick up lab requisition and then kit
    • Other: mailing completed kits in for processing
  • Experimental: Pick-up/Drop-off
    Mailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing.
    Interventions:
    • Other: mailed invitation to pick up lab requisition and then kit
    • Other: dropping completed kits at lab for processing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754896
Other Study ID Numbers  ICMJE 209-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Cancer Care Ontario
Investigators  ICMJE
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
PRS Account Sunnybrook Health Sciences Centre
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP