Clinical trial · Interventional
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
NCT00892593CI-TRIAL-00015138ASC-FITunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Immunochemical Testing | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1 Fecal Immunochemical Testing-Surveillance
- description
- Fecal Immunochemical Testing performed at yearly intervals.
- interventionNames
- Device: Fecal Immunochemical Testing
- type
- NO_INTERVENTION
- label
- 2 Usual Care - Surveillance
- type
- NO_INTERVENTION
- label
- 3 Usual Care - Screening
- type
- EXPERIMENTAL
- label
- 4 Fecal Immunochemical Testing-Screening
- description
- Fecal Immunochemical Testing yearly, beginning at year 6.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Group I (positive colonoscopy) * 18 to 75 years of age * male or female * willing to provide written informed consent * In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam. Group II (negative colonoscopy) * 50 to 69 years of age * Male or female * Willing to provide written informed consent * In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam. Exclusion Criteria: Group I (positive colonoscopy) * chronic use of coumadin * history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis) * age or health status contraindicates repeat colonoscopy * history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome * The index colonoscopy resulted in a perforation requiring surgical repair * An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr. Group II (negative colonoscopy) * chronic use of coumadin * history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis) * age or health status contraindicates repeat colonoscopy * history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome * The index colonoscopy resulted in a perforation requiring surgical repair * Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less
References
Publications (0)
Data not yet available
No reference posted for this study.