Clinical trial · Observational
Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy
Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy (FIT2RUN Study)
- 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)
This is an observational study in a clinical setting to estimate the prevalence of advanced colorectal neoplasia (ACN) at colonoscopy in those with a history of low or high risk polyps or a family history of CRC/polyps and to verify the test performance characteristics of FIT in these populations. Using this information, a risk prediction model will be developed to help guide the choice between FIT and colonoscopy in the ongoing surveillance or screening of patients.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Advanced Colorectal Neoplasia (ACN) Prevalence
- timeFrame
- At time of colonoscopy
- description
- ACN: Colorectal cancer or an advanced adenoma (\> 1 cm, villous features, high grade dysplasia) or serrated polyp (\> 1 cm or any conventional dysplasia).
- measure
- Fecal Immunochemical Test Sensitivity and Specificity
- timeFrame
- FIT test to be completed between 3-42 days prior to participant colonoscopy
- description
- Single fecal sample for measurement of hemoglobin using the OC-Sensor FIT. Positive if measured hemoglobin is ≥100 ng/ml (manufacturers recommended cut off). Sensitivity = proportion of individuals with at least one ACN who had a positive FIT. Specificity = proportion of individuals without advanced lesions who had a negative FIT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men or women age ≤ 74 years of age. 2. At least one risk factor for CRC that would generally lead to colonoscopy screening: 1. Personal history of low risk polyps 2. Personal history of high risk polyps 3. Family history of CRC or polyps Exclusion Criteria: 1. Known acromegaly, cystic fibrosis or high risk profession (firefighter) 2. Referred for colonoscopy due to a positive fecal immunochemical test or CT colonography 3. Known or suspected gene carrier for a familial cancer syndrome. 4. Does not meet medical criteria for colonoscopy at the CCSC. 5. Colonoscopy within the previous 30 months 6. Unable to provide written informed consent or complete questionnaires due to language barrier or other reasons.
References
Publications (0)
Data not yet available