Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
NCT ID: NCT01075633
Last Updated: 2014-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1501 participants
INTERVENTIONAL
2006-01-31
2013-06-30
Brief Summary
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Detailed Description
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Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded.
To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Fecal occult blood testing
Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Immunochemical fecal occult blood test And colonoscopy if test is positive
Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Colonoscopy
Colonoscopy with sedation.
Colonoscopy with sedation
Colonoscopy with sedation
Interventions
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Immunochemical fecal occult blood test And colonoscopy if test is positive
Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Colonoscopy with sedation
Colonoscopy with sedation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
75 Years
ALL
No
Sponsors
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Enrique Quintero
OTHER
Responsible Party
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Enrique Quintero
PhD
Principal Investigators
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Enrique Quintero, MD
Role: STUDY_DIRECTOR
Fundación Canaria para la Investigación Biomédica Rafael Clavijo
Locations
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Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, Spain
Countries
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References
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Gimeno-Garcia AZ, Quintero E, Nicolas-Perez D, Hernandez-Guerra M, Parra-Blanco A, Jimenez-Sosa A. Screening for familial colorectal cancer with a sensitive immunochemical fecal occult blood test: a pilot study. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1062-7. doi: 10.1097/MEG.0b013e3283293797.
Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
Other Identifiers
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COLONFAM
Identifier Type: -
Identifier Source: org_study_id
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