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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria:
1. Men or women age ≤ 74 years of age.
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:
1. Known acromegaly, cystic fibrosis or high risk profession (firefighter)
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.
Primary outcome measure(s)
Advanced Colorectal Neoplasia (ACN) Prevalence — At time of colonoscopy ACN: Colorectal cancer or an advanced adenoma (\> 1 cm, villous features, high grade dysplasia) or serrated polyp (\> 1 cm or any conventional dysplasia).
Fecal Immunochemical Test Sensitivity and Specificity — FIT test to be completed between 3-42 days prior to participant colonoscopy 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.
Trial sites (1)
Facility
City
Region
Status
Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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