Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05396560

Conditions

Colorectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Colorectal Neoplasms

Study ID

NCT05396560

Start date

Apr 15, 2022

Status verified date

May, 2022

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Advanced Colorectal Neoplasia (ACN) Prevalence [ Time Frame: At time of colonoscopy ]
  • Fecal Immunochemical Test Sensitivity and Specificity [ Time Frame: FIT test to be completed between 3-42 days prior to participant colonoscopy ]

Central Contacts and Locations

Central contacts

Robert Hilsden, MD PhD

403-592-5089rhilsden@ucalgary.ca

Susanna Town, PhD

403-592-5052susanna.town@ucalgary.ca

Locations

Forzani & Macphail Colon Cancer Screening Centre, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Robert Hilsden

1-403-592-5089rhilsden@ucalgary.ca

Susanna Town

1-403-592-5052susanna.town@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

May 31, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-05-31.