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Colonoscopy Screening for Colorectal Cancer Risk in IBD
N/A
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will compare strategies for colorectal neoplasia screening in people with IBD, to see if one is better at finding cancerous lesions. 1952 participants needed.
Who is the study for?
This trial is for adults over 18 with Inflammatory Bowel Disease (IBD) who are in symptomatic remission and have had IBD for at least 8 years, or any duration if they also have primary sclerosing cholangitis. They should be undergoing colorectal cancer screening with a high-definition colonoscopy but can't join if they've had major colon surgery, recent neoplasia diagnosis, poor bowel prep quality, incomplete colonoscopy, significant inflammation or a history of colorectal cancer.Check my eligibility
What is being tested?
The study compares two strategies during high-definition white light colonoscopies: one where only visible lesions are sampled versus the conventional method that samples both visible lesions and normal-appearing mucosa. The goal is to see which strategy is better at detecting neoplasia without being worse than the other. A total of 1952 participants will be enrolled to determine this.See study design
What are the potential side effects?
While not explicitly stated here, standard side effects from a colonoscopy may include abdominal pain or discomfort, bloating, gas cramps and potential risk of bleeding or perforation from biopsy procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of persons with ≥ 1 neoplastic lesion detected
Secondary outcome measures
CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)
Mean # high grade dysplastic lesions or colorectal cancers per person
Mean # tissue samples per person
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
563 Previous Clinical Trials
2,785,765 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had more than half of my colon removed.I am scheduled for a follow-up colonoscopy due to a recent cancer diagnosis.My colon inflammation is moderate to severe, affecting at least 25% of it, or mild but affecting at least 50%.I am 18 years old or older.I have had inflammatory bowel disease for 8 years or more, or I have it with primary sclerosing cholangitis.I am scheduled for or have had a full colon examination using special dye or virtual imaging.My last colonoscopy showed poor visibility even after cleaning.I am not experiencing symptoms at the time of my colonoscopy.I have a history of colorectal cancer.I am unable to understand and give consent for treatment.I am scheduled for a detailed colonoscopy using advanced imaging.My colonoscopy is mainly for cancer screening.My colonoscopy did not examine my entire colon.My ulcerative colitis or Crohn's disease affects more than just my rectum.Your Harvey-Bradshaw Index is below 541.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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