Trials / Completed
CompletedNCT00906997
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55,498 (actual)
- Sponsor
- Hospital Clinic of Barcelona · Academic / Other
- Sex
- All
- Age
- 50 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
Aims: 1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population. 2. To determine the compliance and complications associated with both strategies. Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia). Study groups: * Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result. * Group II: colonoscopy. Sample-size calculation: 27,749 subjects in each study group (total: 55,498).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Immunochemical fecal occult blood test | Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml. |
| PROCEDURE | Colonoscopy | Every 10 years, with sedation. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2009-05-21
- Last updated
- 2025-03-18
Locations
8 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00906997. Inclusion in this directory is not an endorsement.