Clinical trial · Interventional
Pilot Evaluation of Fecal Immunologic Test (FIT) in Ontario
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dropping completed kits at lab for processing | Other | — | UNRESOLVED |
| mailed invitation to pick up lab requisition and then kit | Other | — | UNRESOLVED |
| mailing completed kits in for processing | Other | — | UNRESOLVED |
| mailing of FIT kit directly to patient | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Mail-out/Mail-back
- description
- Mailing of FIT kit directly to patient. Mailing completed kits in for processing.
- interventionNames
- Other: mailing of FIT kit directly to patient
- Other: mailing completed kits in for processing
- type
- EXPERIMENTAL
- label
- Mail-out/Drop-off
- description
- Mailing of FIT kit directly to patient. Dropping completed kits at lab for processing.
- interventionNames
- Other: mailing of FIT kit directly to patient
- Other: dropping completed kits at lab for processing
- type
- EXPERIMENTAL
- label
- Pick-up/Mail-back
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Physician in Ontario with a patient enrollment model * patient: 50-74, Ontario resident, enrolled with physician Exclusion Criteria: * patient: no personal or first degree relative family history of CRC, no FOBT within prior 5 years, colonoscopy within past 10 years, FOBT within past 2 years
References
Publications (0)
Data not yet available