Colorectal NeoplasmsFIT2RUNNCT05396560
Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy
An observational study of Colorectal Neoplasms, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 3,000 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2022to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Forzani & Macphail Colon Cancer Screening Centre, University of Calgary
Calgary, Alberta, T2N 4N1
Robert Hilsden, 1-403-592-5089, rhilsden@ucalgary.ca
Susanna Town, 1-403-592-5052, susanna.town@ucalgary.ca
About this study
Official title: Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy (FIT2RUN Study)
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.
Read the detailed description
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:
- Contemporary data is lacking on the prevalence of advanced and non-advanced colorectal neoplasia at colonoscopy in a cohort of individuals with well characterized index pathology and/or family history of CRC/polyps.
- There is limited data on the sensitivity and specificity of FIT for the detection of advanced colorectal neoplasia in these settings.
- The factors that predict a higher risk of advanced colorectal neoplasia in those undergoing for post-polypectomy surveillance or a family history are unknown.
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.
- Conditions
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: FIT test to be completed between 3-42 days prior to participant colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Apr 2022
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hilsden, MD PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396560
- Sponsor's protocol ID
- FIT2RUN01
- Acronym
- FIT2RUN
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy (FIT2RUN Study)
- ClinicalTrials.gov ID
- NCT05396560
- Acronym / sponsor ID
- FIT2RUN / FIT2RUN01
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Contemporary data is lacking on the prevalence of advanced and non-advanced colorectal neoplasia at colonoscopy in a cohort of individuals with well characterized index pathology and/or family history of CRC/polyps.
- There is limited data on the sensitivity and specificity of FIT for the detection of advanced colorectal neoplasia in these settings.
- The factors that predict a higher risk of advanced colorectal neoplasia in those undergoing for post-polypectomy surveillance or a family history are unknown.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Men or women age ≤ 74 years of age.
- At least one risk factor for CRC that would generally lead to colonoscopy screening:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advanced Colorectal Neoplasia (ACN) Prevalence
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Hilsden, MD PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Hilsden, MD PhD (403-592-5089, rhilsden@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced Colorectal Neoplasia (ACN) Prevalence (time frame: At time of colonoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.