Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario

Summary

Prior to implementation of new colorectal cancer (CRC) screening technology (fecal immunochemical test - FIT) in Ontario, there is a need for a laboratory and field assessment to validate and optimize its use in the Ontario climate and conditions (e.g., large geographic area) and to determine whether adjustments to the current structure of the ColonCancerCheck (CCC) Program would be required.

This study consists of 2 phases. Phase 1 consists of laboratory testing of FIT kits to evaluate analytical performance relevant to the requirements of the CCC Program. Phase 2 is a field assessment to evaluate the effect of different distribution and return methods and pre-labeling of kits on uptake and completion of the tests. The entire study will take 12-18 months to complete, with patients being recruited through family physicians in patient enrollment model (PEM) family practices across the province of Ontario.

This Clinical Trials registration relates to Phase 2 of the study.

Conditions

• Colorectal Cancer

Interventions

OTHER

mailing of FIT kit directly to patient

Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.

OTHER

mailed invitation to pick up lab requisition and then kit

Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.

OTHER

mailing completed kits in for processing

Patients mails completed kit in for processing using postage-paid reply envelope provided.

OTHER

dropping completed kits at lab for processing

Patient takes completed FIT in to lab patient service centre for processing.

Sponsors & Collaborators

• Cancer Care Ontario

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Jill Tinmouth, MD, PhD · Sunnybrook Research Institute

• Linda Rabeneck, MD, MPH · Cancer Care Ontario

• Lawrence Paszat, MD, SM · Institute for Clinical Evaluative Studies (ICES)

• Nancy Baxter, MD, PhD · St. Michaels Hospital

• Edward Randall, PhD, DCC · Eastern Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• Canada

Study Locations