Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
This is an observational, controlled, randomized phase III study to evaluate the
effectiveness of the iFOBT for detecting advanced neoplasia (polyps > 1cm in size, high
grade dysplasia or with villous component, or CRC) in first degree relatives of patients
with CRC.
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]
2 years
No
Enrique Quintero, MD
Study Director
Fundación Canaria para la Investigación Biomédica Rafael Clavijo
Spain: Spanish Agency of Medicines
COLONFAM
NCT01075633
September 2008
December 2012
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