Inflammatory Bowel DiseasesIBDDysplasiaNCT04067778
IBD Neoplasia Surveillance Pilot RCT
A study testing Intervention Group in people with Inflammatory Bowel Diseases and Colonic Neoplasms, run by Ottawa Hospital Research Institute at 12 sites in Canada.
Trial summary
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Colonic Neoplasms, Dysplasia
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 12 sitesCanada
- Study dates
- 6 Nov 2020to 6 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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 cannot or are unwilling to provide informed consent
- Persons with a history of colorectal cancer
- Persons with prior subtotal or total colectomy (> 50% of colon removed)
- Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- Persons undergoing pancolonic 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)
- Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
University of Alberta
Edmonton, Alberta
Nova Scotia Health Authority
Halifax, Nova Scotia
Hamilton Health Sciences Corporation
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
Pacific Digestive Health / Royal Jubilee Hospital
Victoria, British Columbia
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.
Read the detailed description
Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence.
In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.
Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.
- Conditions
- Inflammatory Bowel Diseases, Colonic Neoplasms, Dysplasia
- Being tested
- Intervention Group, Control Group
- Keywords
- IBD, Dysplasia, Biopsy, Colonoscopy
- Medical subject headings
- Inflammatory Bowel Diseases, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDiagnostic test
Standard colonoscopy with targeted biopsies only
Control GroupDiagnostic test
Standard colonoscopy with random AND targeted biopsies
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Diagnostic Test: Intervention Group |
| Control Group | Other | Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken. Receives: Diagnostic Test: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Number of Participants Enrolled
Number of participants enrolled within one year from the overall total required.
Measured: 1 year
Rate of Protocol Adherence
Rate of protocol adherence of major protocol violations on a per-patient basis.
Measured: 1 year
Rate of overall neoplasia detection
Overall neoplasia detection rate for the definitive trial.
Measured: 1 year
Adverse Events occurrence
Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.
Measured: 2 weeks
Secondary outcomes (2)
Rate of Study Variables
Measured: 1 year
Rate of Missed 2-Week Post-Procedural Assessment for Complications
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start6 Nov 2020
- Primary completion20 Sep 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba, Western University, Canada, University of Toronto, Hamilton Health Sciences Corporation, Thunder Bay Regional Health Sciences Centre, Eastern Health, McGill University Health Centre/Research Institute of the McGill University Health Centre, Providence Health & Services, Royal Jubilee Hospital, University of Alberta, MOUNT SINAI HOSPITAL, Nova Scotia Health Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067778
- Sponsor's protocol ID
- 20190428-01T
- Acronym
- IBDDysplasia
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murthy SK, Marderfeld L, Fergusson D, Ramsay T, Bernstein CN, Nguyen GC, Jairath V, Riddell R. A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol. Pilot Feasibility Stud. 2024 Feb 1;10(1):20. doi: 10.1186/s40814-023-01434-8.
PubMed 38297397
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study
- ClinicalTrials.gov ID
- NCT04067778
- Acronym / sponsor ID
- IBDDysplasia / 20190428-01T
- Conditions
- Inflammatory Bowel Diseases, Colonic Neoplasms, Dysplasia
- Keywords
- IBD, Dysplasia, Biopsy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba, Western University, Canada, University of Toronto, Hamilton Health Sciences Corporation, Thunder Bay Regional Health Sciences Centre, Eastern Health, McGill University Health Centre/Research Institute of the McGill University Health Centre, Providence Health & Services, Royal Jubilee Hospital, University of Alberta, MOUNT SINAI HOSPITAL, Nova Scotia Health Authority
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 26 Aug 2019 (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.
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.
Detailed description
Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence.
In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.
Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Diagnostic Test: Intervention GroupParticipants 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. |
| Control Group | Other | Diagnostic Test: Control GroupParticipants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 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
Key exclusion criteria (8 listed)
- Persons who cannot or are unwilling to provide informed consent
- Persons with a history of colorectal cancer
- Persons with prior subtotal or total colectomy (> 50% of colon removed)
- Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- Persons undergoing pancolonic 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 |
|---|---|---|
| Intervention GroupStandard colonoscopy with targeted biopsies only | Diagnostic test | Intervention Group |
| Control GroupStandard colonoscopy with random AND targeted biopsies | Diagnostic test | Control Group |
Primary outcome
Overall Number of Participants Enrolled
Time frame: 1 year
Number of participants enrolled within one year from the overall total required.
Rate of Protocol Adherence
Time frame: 1 year
Rate of protocol adherence of major protocol violations on a per-patient basis.
Rate of overall neoplasia detection
Time frame: 1 year
Overall neoplasia detection rate for the definitive trial.
Adverse Events occurrence
Time frame: 2 weeks
Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.
2 secondary outcomes
Rate of Study Variables
Time frame: 1 year
Rate of Missed 2-Week Post-Procedural Assessment for Complications
Time frame: 2 weeks
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 31 Mar 2023.
- Derived from this study: PubMed 38297397Murthy SK, Marderfeld L, Fergusson D, Ramsay T, Bernstein CN, Nguyen GC, Jairath V, Riddell R. A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol. Pilot Feasibility Stud. 2024 Feb 1;10(1):20. doi: 10.1186/s40814-023-01434-8.
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease
Crohn Disease (CD)
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Inflammatory Bowel Diseases and Colonic Neoplasms, run by Ottawa Hospital Research Institute at 12 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 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Overall Number of Participants Enrolled (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04067778, which also lists 1 linked publication.
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 Mar 2023.