NCT05396560 Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy
| NCT ID | NCT05396560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-04-15 |
| Primary Completion | 2026-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-04-15 with a primary completion date of 2026-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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.
Contact & Investigator
Robert Hilsden, MD PhD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05396560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 74 Years, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05396560 currently recruiting?
Yes, NCT05396560 is actively recruiting participants. Contact the research team at rhilsden@ucalgary.ca for enrollment information.
Where is the NCT05396560 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05396560 clinical trial?
NCT05396560 is sponsored by University of Calgary. The principal investigator is Robert Hilsden, MD PhD at University of Calgary. The trial plans to enroll 3,000 participants.