Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive; Procedure: Colonoscopy with sedation

• Registration Number: NCT01075633
• Lead Sponsor: Enrique Quintero

Brief Summary

This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.

Detailed Description

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

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2011-12
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1501

Inclusion Criteria

• Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC

Exclusion Criteria

• Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal occult blood testing	Immunochemical fecal occult blood test And colonoscopy if test is positive	Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Colonoscopy	Colonoscopy with sedation	Colonoscopy with sedation.

Primary Outcome Measures

Name	Time	Method
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]	2 years

Secondary Outcome Measures

Name	Time	Method
Complications rate	2 years

Trial Locations

Locations (1)

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain