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This is an observational study 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.
Colonoscopy is an effective tool in reducing colorectal cancer (CRC) incidence, however, it is a limited resource that is not without risk. The overall goal of this study is to determine if Fecal Immunochemical Tests (FIT) could be an effective alternative to colonoscopy for the surveillance of patients at increased risk for CRC. The rationale for this project is that colonoscopy is both a more expensive (30-40X) and more limited resource than FIT, which because of its pivotal role in the investigation and management of many gastrointestinal conditions is constantly in demand.
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Advanced Colorectal Neoplasia (ACN) Prevalence | ACN: Colorectal cancer or an advanced adenoma (> 1 cm, villous features, high grade dysplasia) or serrated polyp (> 1 cm or any conventional dysplasia). | At time of colonoscopy |
| Fecal Immunochemical Test Sensitivity and Specificity | Single fecal sample for measurement of hemoglobin using the OC-Sensor FIT. Positive if measured hemoglobin is ≥100 ng/ml (manufacturers recommended cut off). Sensitivity = proportion of individuals with at least one ACN who had a positive FIT. Specificity = proportion of individuals without advanced lesions who had a negative FIT. | FIT test to be completed between 3-42 days prior to participant colonoscopy |
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Inclusion Criteria:
Men or women age ≤ 74 years of age.
At least one risk factor for CRC that would generally lead to colonoscopy screening:
Exclusion Criteria:
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Participants will include eligible individuals referred to CCSC due to a personal history of low or high risk polyps and/or a family history of CRC/polyps who are medically fit and eligible to undergo colonoscopy at the Centre
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Hilsden, MD PhD | Contact | 403-592-5089 | rhilsden@ucalgary.ca | |
| Susanna Town, PhD | Contact | 403-592-5052 | susanna.town@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Robert Hilsden, MD PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forzani & Macphail Colon Cancer Screening Centre, University of Calgary | Recruiting | Calgary | Alberta | T2N 4N1 | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |