Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy

NCT05396560 | Recruiting

• 1 other identifier: FIT2RUN01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Men or women age ≤ 74 years of age.
• At least one risk factor for CRC that would generally lead to colonoscopy screening:
• Personal history of low risk polyps
• Personal history of high risk polyps
• Family history of CRC or polyps

You may not qualify if:

• Known acromegaly, cystic fibrosis or high risk profession (firefighter)
• Referred for colonoscopy due to a positive fecal immunochemical test or CT colonography
• Known or suspected gene carrier for a familial cancer syndrome.
• Does not meet medical criteria for colonoscopy at the CCSC.
• Colonoscopy within the previous 30 months
• Unable to provide written informed consent or complete questionnaires due to language barrier or other reasons.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani & Macphail Colon Cancer Screening Centre, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Robert Hilsden, MD PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Hilsden, MD PhD

CONTACT

403-592-5089; rhilsden@ucalgary.ca

Susanna Town, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 31, 2022
• Study Start: April 15, 2022
• Primary Completion: April 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

CA (1)