Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy
NCT ID: NCT05396560
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2022-04-15
2027-04-15
Brief Summary
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Detailed Description
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Routine post-polypectomy surveillance is placing a rapidly growing demand on existing colonoscopy resources, driven in part by the rapid expansion of CRC screening programs.(1) Currently, there are not strong contemporary data to guide the use of colonoscopy or alternative tests for the surveillance of patients after the removal of low or high risk polyps, but colonoscopy is routinely recommended by screening guidelines, as historically no other reasonable options existed. Colonoscopy screening is also the default recommendation for individuals with a family history of CRC or polyps.
It is proposed that the highly sensitive and low cost FIT could replace colonoscopy for post-polypectomy surveillance and primary screening in at least some patients and, thereby, reduce costs while improving access to colonoscopy for other patients.
The following knowledge gaps must be filled prior to advocating the use of FIT for post-polypectomy surveillance or primary screening:
1. Contemporary data is lacking on the prevalence of advanced and non-advanced colorectal neoplasia at colonoscopy in a cohort of individuals with well characterized index pathology and/or family history of CRC/polyps.
2. There is limited data on the sensitivity and specificity of FIT for the detection of advanced colorectal neoplasia in these settings.
3. The factors that predict a higher risk of advanced colorectal neoplasia in those undergoing for post-polypectomy surveillance or a family history are unknown.
This is an observational study conducted in a clinical setting to estimate the prevalence of advanced colorectal neoplasia (ACN) at colonoscopy in those with a history of low or high risk polyps or a family history of CRC/polyps and to verify the test performance characteristics of FIT in these populations. Using this information, a risk prediction model will be developed to help guide the choice between FIT and colonoscopy in the ongoing surveillance or screening of patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. At least one risk factor for CRC that would generally lead to colonoscopy screening:
1. Personal history of low risk polyps
2. Personal history of high risk polyps
3. Family history of CRC or polyps
Exclusion Criteria
2. Referred for colonoscopy due to a positive fecal immunochemical test or CT colonography
3. Known or suspected gene carrier for a familial cancer syndrome.
4. Does not meet medical criteria for colonoscopy at the CCSC.
5. Colonoscopy within the previous 30 months
6. Unable to provide written informed consent or complete questionnaires due to language barrier or other reasons.
18 Years
74 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Robert Hilsden, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Robert Hilsden
Role: primary
Susanna Town
Role: backup
Other Identifiers
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FIT2RUN01
Identifier Type: -
Identifier Source: org_study_id