Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Study Overview
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Brief Summary
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Aims: 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. 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).

Official Title
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Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Conditions
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Colorectal Cancer, Colorectal Neoplasm

Intervention / Treatment
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* Procedure: Immunochemical fecal occult blood test
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 50-69 years Exclusion Criteria: Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60) Severe comorbidity Previous total colectomy Not signed informed consent to participate

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fecal occult blood testing<br> | Procedure: Immunochemical fecal occult blood test<br>* Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.<br>|
| Active Comparator: Colonoscopy<br> | Procedure: Colonoscopy<br>* Every 10 years, with sedation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal cancer-related mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate |  | 2 years | 
| Complication rate |  | 10 years | 
| Colorectal cancer incidence |  | 15 years | 
| Adherence rate |  | 10 years | 
| Advanced colorectal neoplasm detection rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Screening, Prevention, Fecal occult blood test, Colonoscopy, Colorectal neoplasm, Randomized clinical trial