IBD Neoplasia Surveillance Pilot RCT

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 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.

Conditions

• Inflammatory Bowel Diseases
• Colonic Neoplasms
• Dysplasia

Interventions

DIAGNOSTIC_TEST

Intervention Group

Standard colonoscopy with targeted biopsies only

DIAGNOSTIC_TEST

Control Group

Standard colonoscopy with random AND targeted biopsies

Sponsors & Collaborators

• Health Sciences Centre, Winnipeg, Manitoba

  collaborator OTHER

• Western University, Canada

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• Thunder Bay Regional Health Sciences Centre

  collaborator OTHER

• Eastern Health

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Providence Health & Services

  collaborator OTHER

• Royal Jubilee Hospital

  collaborator UNKNOWN

• University of Alberta

  collaborator OTHER

• MOUNT SINAI HOSPITAL

  collaborator OTHER

• Nova Scotia Health Authority

  collaborator OTHER

• Ottawa Hospital Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-06

Primary Completion

2022-09-20

Completion

2022-10-06

Countries

• Canada

Study Locations