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IBD Neoplasia Surveillance RCT

Primary Purpose

Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard colonoscopy with targeted biopsies
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Neoplasms focused on measuring Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 For UC or IBDU: Partial Mayo Score ≤ 242 Major purpose of colonoscopy is neoplasia screening/surveillance Undergoing colonoscopy with high-definition white light endoscopy Exclusion Criteria: 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

Sites / Locations

  • University of AlbertaRecruiting
  • St. Paul's HospitalRecruiting
  • University of Manitoba, Health Sciences CentreRecruiting
  • Eastern Regional Health AuthorityRecruiting
  • Nova Scotia Health AuthorityRecruiting
  • Hamilton Health SciencesRecruiting
  • London Health Sciences Centre, University HospitalRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • Thunder Bay Regional Health Sciences CentreRecruiting
  • Mount Sinai Hospital
  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of persons with ≥ 1 neoplastic lesion detected

Secondary Outcome Measures

Mean number of neoplastic lesions per person
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected
Mean # high grade dysplastic lesions or colorectal cancers per person
Mean # tissue samples per person
Mean procedure time
Rate of major adverse events within 2 weeks of procedure (as per pilot study)
Proportion of persons referred for colectomy based on neoplastic findings
Mean time to next recommended surveillance examination
CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)

Full Information

First Posted
March 30, 2023
Last Updated
March 30, 2023
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05809999
Brief Title
IBD Neoplasia Surveillance RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Inflammatory Bowel Diseases, Dysplasia
Keywords
Inflammatory Bowel Disease, Dysplasia, Biopsy, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1952 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard colonoscopy with targeted biopsies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of persons with ≥ 1 neoplastic lesion detected
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Mean number of neoplastic lesions per person
Time Frame
4 years
Title
Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected
Time Frame
4 years
Title
Mean # high grade dysplastic lesions or colorectal cancers per person
Time Frame
4 years
Title
Mean # tissue samples per person
Time Frame
4 years
Title
Mean procedure time
Time Frame
4 years
Title
Rate of major adverse events within 2 weeks of procedure (as per pilot study)
Time Frame
4 years
Title
Proportion of persons referred for colectomy based on neoplastic findings
Time Frame
4 years
Title
Mean time to next recommended surveillance examination
Time Frame
4 years
Title
CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 For UC or IBDU: Partial Mayo Score ≤ 242 Major purpose of colonoscopy is neoplasia screening/surveillance Undergoing colonoscopy with high-definition white light endoscopy Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Murthy, MD
Phone
(613)737-8899
Ext
73542
Email
smurthy@toh.ca
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Hoentjen
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Bressler
Facility Name
University of Manitoba, Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Bernstein
Facility Name
Eastern Regional Health Authority
City
St. John's
State/Province
NFLD
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Borgaonkar
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Jones
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Castelli
Phone
289-880-3609
Email
jcast@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Neeraj Narula, MD
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vipul Jairath
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Murthy
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petros Zezos
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoff Nguyen
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talat Bessissow

12. IPD Sharing Statement

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IBD Neoplasia Surveillance RCT

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