Colorectal CancerNCT01754896
Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
A study testing mailing of FIT kit directly to patient, mailed invitation to pick up lab requisition and then kit and mailing completed kits in for processing in people with Colorectal Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mailing of FIT kit directly to patient, mailed invitation to pick up lab requisition and then kit and mailing completed kits in for processing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physician in Ontario with a patient enrollment model
- patient: 50-74, Ontario resident, enrolled with physician
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- 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
- Keywords
- colorectal cancer, fecal immunochemical test, fecal occult blood test, screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mailing of FIT kit directly to patientOther
Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
mailed invitation to pick up lab requisition and then kitOther
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.
mailing completed kits in for processingOther
Patients mails completed kit in for processing using postage-paid reply envelope provided.
dropping completed kits at lab for processingOther
Patient takes completed FIT in to lab patient service centre for processing.
| Study group | Role | What they receive |
|---|---|---|
| Mail-out/Mail-back | Experimental | Mailing of FIT kit directly to patient. Mailing completed kits in for processing. Receives: Other: mailing of FIT kit directly to patient; Other: mailing completed kits in for processing |
| Mail-out/Drop-off | Experimental | Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing. Receives: Other: mailing of FIT kit directly to patient; Other: dropping completed kits at lab for processing |
| Pick-up/Mail-back | Experimental | Mailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing. Receives: Other: mailed invitation to pick up lab requisition and then kit; Other: mailing completed kits in for processing |
| Pick-up/Drop-off | Experimental | Mailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing. Receives: Other: mailed invitation to pick up lab requisition and then kit; Other: dropping completed kits at lab for processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2012 to April 2013
Secondary outcomes (1)
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.
Measured: September 2012 to April 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Jill Tinmouth, MD, PhD, Principal investigator, Sunnybrook Research InstituteLinda Rabeneck, MD, MPH, Principal investigator, Cancer Care OntarioLawrence Paszat, MD, SM, Principal investigator, Institute for Clinical Evaluative Studies (ICES)Nancy Baxter, MD, PhD, Principal investigator, St. Michaels HospitalEdward Randall, PhD, DCC, Principal investigator, Eastern Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754896
- Sponsor's protocol ID
- 209-2011
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
- ClinicalTrials.gov ID
- NCT01754896
- Acronym / sponsor ID
- 209-2011
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, fecal immunochemical test, fecal occult blood test, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mail-out/Mail-back | Experimental | Other: mailing of FIT kit directly to patient, Other: mailing completed kits in for processingMailing of FIT kit directly to patient. Mailing completed kits in for processing. |
| Mail-out/Drop-off | Experimental | Other: mailing of FIT kit directly to patient, Other: dropping completed kits at lab for processingMailing of FIT kit directly to patient. Dropping completed kits at lab for processing. |
| Pick-up/Mail-back | Experimental | Other: mailed invitation to pick up lab requisition and then kit, Other: mailing completed kits in for processingMailed invitation to pick up lab requisition and then kit. Mailing completed kits in for processing. |
| Pick-up/Drop-off | Experimental | Other: mailed invitation to pick up lab requisition and then kit, Other: dropping completed kits at lab for processingMailed invitation to pick up lab requisition and then kit. Dropping completed kits at lab for processing. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician in Ontario with a patient enrollment model
- patient: 50-74, Ontario resident, enrolled with physician
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mailing of FIT kit directly to patientPatient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included. | Other | Mail-out/Drop-off, Mail-out/Mail-back |
| mailed invitation to pick up lab requisition and then kitPatients 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 | Pick-up/Drop-off, Pick-up/Mail-back |
| mailing completed kits in for processingPatients mails completed kit in for processing using postage-paid reply envelope provided. | Other | Mail-out/Mail-back, Pick-up/Mail-back |
| dropping completed kits at lab for processingPatient takes completed FIT in to lab patient service centre for processing. | Other | Mail-out/Drop-off, Pick-up/Drop-off |
Primary outcome
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.
1 secondary outcome
Rejection rates
Time frame: September 2012 to April 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Tinmouth, MD, PhD principal investigator
Sunnybrook Research Institute
Linda Rabeneck, MD, MPH principal investigator
Cancer Care Ontario
Lawrence Paszat, MD, SM principal investigator
Institute for Clinical Evaluative Studies (ICES)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mailing of FIT kit directly to patient, mailed invitation to pick up lab requisition and then kit and mailing completed kits in for processing in people with Colorectal Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT Kit uptake (time frame: September 2012 to April 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.