Colonic NeoplasmsNCT05809999
IBD Neoplasia Surveillance RCT
A study testing Standard colonoscopy with targeted biopsies in people with Colonic Neoplasms and Inflammatory Bowel Diseases, run by Ottawa Hospital Research Institute at 11 sites in Canada.
Trial summary
We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia
- What is being tested?
- Standard colonoscopy with targeted biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,411 participants
- Where
- 11 sitesCanada
- Study dates
- 23 Sep 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each potential participant must satisfy all of the following criteria to be enrolled in the study.
- ≥ 18 years old
- Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD)
- cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)
- In symptomatic remission at time of colonoscopy
- For CD: Harvey-Bradshaw Index < 541
Show all 9Show fewer
- For UC or IBDU: Partial Mayo Score ≤ 242
- Major purpose of colonoscopy is neoplasia screening/surveillance
- Undergoing colonoscopy with high-definition white light endoscopy
Who cannot join
- Persons who are unable to provide informed consent
- Persons with a history of colorectal cancer
- Persons with prior subtotal or total colectomy (>50% of colon removed)
- Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy
- Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)
- Incomplete colonoscopy (unable to reach cecum or terminal ileum [if no cecum])
- Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
University of Alberta
Edmonton, Alberta
Nova Scotia Health Authority
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario, L8L 8E7
London Health Sciences Centre, University Hospital
London, Ontario
McGill University Health Centre
Montreal, Quebec
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Eastern Regional Health Authority
St. John's, NFLD, A1B 3V6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Mount Sinai Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.
- Conditions
- Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia
- Being tested
- Standard colonoscopy with targeted biopsies
- Keywords
- Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy
- Medical subject headings
- Colonic Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard colonoscopy with targeted biopsiesProcedure or surgery
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any areas suspicious for neoplastic/dysplastic lesions observed by the doctor) and/or removal of any polyps will be undertaken. A limited number of disease staging biopsies from each segment of the colorectum will be permitted. Receives: Procedure: Standard colonoscopy with targeted biopsies |
| Control Group | No intervention | Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40 non-targeted biopsies) and targeted sampling (biopsies and/or removal of suspicious pre-cancerous lesions) will be undertaken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of persons with ≥ 1 neoplastic lesion detected
Measured: 4 years
Secondary outcomes (7)
Mean number of neoplastic lesions per person
Measured: 4 years
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer
Measured: 4 years
Mean # high grade dysplastic lesions or colorectal cancers per person
Measured: 4 years
Mean # non-targeted (random) biopsies per person
Measured: 4 years
Mean procedure time
Measured: 4 years
Rate of major adverse events within 2 weeks of procedure (as per pilot study)
Measured: 4 years
Mean time to next recommended surveillance examination
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start23 Sep 2022
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809999
- Sponsor's protocol ID
- CTO1769
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05809999
- Acronym / sponsor ID
- CTO1769
- Conditions
- Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia
- Keywords
- Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,411 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 12 Apr 2023 (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.
We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Procedure: Standard colonoscopy with targeted biopsiesParticipants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any areas suspicious for neoplastic/dysplastic lesions observed by the doctor) and/or removal of any polyps will be undertaken. A limited number of disease staging biopsies from each segment of the colorectum will be permitted. |
| Control Group | No intervention | –Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40 non-targeted biopsies) and targeted sampling (biopsies and/or removal of suspicious pre-cancerous lesions) will be undertaken. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Each potential participant must satisfy all of the following criteria to be enrolled in the study.
Key exclusion criteria (8 listed)
- Persons who are unable to provide informed consent
- Persons with a history of colorectal cancer
- Persons with prior subtotal or total colectomy (>50% of colon removed)
- Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard colonoscopy with targeted biopsiesParticipants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken. | Procedure or surgery | Experimental: Intervention Group |
Primary outcome
Proportion of persons with ≥ 1 neoplastic lesion detected
Time frame: 4 years
7 secondary outcomes
Mean number of neoplastic lesions per person
Time frame: 4 years
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer
Time frame: 4 years
Mean # high grade dysplastic lesions or colorectal cancers per person
Time frame: 4 years
Mean # non-targeted (random) biopsies per person
Time frame: 4 years
Mean procedure time
Time frame: 4 years
Rate of major adverse events within 2 weeks of procedure (as per pilot study)
Time frame: 4 years
Mean time to next recommended surveillance examination
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard colonoscopy with targeted biopsies in people with Colonic Neoplasms and Inflammatory Bowel Diseases, run by Ottawa Hospital Research Institute at 11 sites 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of persons with ≥ 1 neoplastic lesion detected (time frame: 4 years). 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 7 Jul 2026.