Experimental: Intervention Group for Colorectal Cancer

Mount Sinai Hospital, Toronto, Canada
Colorectal Cancer+2 More ConditionsStandard colonoscopy with targeted biopsies - Procedure
Eligibility
18 - 100
All Sexes

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.

Eligible Conditions
  • Colorectal Cancer
  • Dysplasia
  • Inflammatory Bowel Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 4 years

4 years
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
Mean number of neoplastic lesions per person
Mean procedure time
Mean time to next recommended surveillance examination
Proportion of persons referred for colectomy based on neoplastic findings
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected
Proportion of persons with ≥ 1 neoplastic lesion detected
Rate of major adverse events within 2 weeks of procedure (as per pilot study)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control Group
1 of 2
Experimental: Intervention Group
1 of 2

Active Control

Experimental Treatment

1952 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental: Intervention Group · No Placebo Group · N/A

Experimental: Intervention Group
Procedure
Experimental Group · 1 Intervention: Standard colonoscopy with targeted biopsies · Intervention Types: Procedure
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
544 Previous Clinical Trials
2,516,055 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Is this research endeavor accepting individuals older than thirty-five?

"This medical trial is searching for eligible participants who are within the age range of 18 to 100 years old." - Anonymous Online Contributor

Unverified Answer

Am I qualified to partake in this investigation?

"1952 participants with inflammatory bowel disease are needed for this research. Eligible individuals must be between 18 and 100 years of age to qualify." - Anonymous Online Contributor

Unverified Answer

What is the maximum enrollment capacity of this clinical trial?

"Yes, according to the information found on clinicaltrials.gov this trial is currently enrolling participants with recruitment commencing on September 23rd 2022 and last updated March 30th 2023. This medical experiment requires 1952 volunteers across 11 different sites." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies within this investigation?

"Affirmative. According to clinicaltrials.gov, this examination is in the process of seeking volunteers. The trial was first posted on September 23rd 2022 and was most recently refreshed on March 30th 2023; it aims to enroll 1952 subjects at 11 different sites." - Anonymous Online Contributor

Unverified Answer

Could you please outline the number of healthcare facilities that are currently administering this trial?

"Currently, there are 11 sites recruiting for this trial including St. Paul's Hospital in Vancouver, University of Manitoba, Health Sciences Centre in Winnipeg and Eastern Regional Health Authority in St. John's as well as a handful of other medical centres." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.