Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Colonoscopy

• Registration Number: NCT01251666
• Lead Sponsor: University Hospital, Caen

Brief Summary

Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2012-06
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19797

Inclusion Criteria

• 50 to 74 years
• Informed consent signed

Exclusion Criteria

• Recent digestive symptoms
• Complete colonoscopy less than 5 years ago
• Personal history of colorectal cancer or colorectal adenoma or colonic disease requiring regular colonoscopy surveillance
• Familial history of colorectal cancer in a first degree next of kin before 65 years, or two cases in first degree next of kin.
• Severe extra-intestinal disease
• Screening ill-timed (ex. depression)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magstream + Oc Sensor + Hemoccult II	Colonoscopy	Each patient will perform all three tests: * Magstream: 2 samples (each on a different stool) * OC Sensor: 2 samples (each on a different stool) * Hemoccult II: 6 samples (2 samples per stool, on 3 different stools) Each test will be considered as positive if at least one sample is positive (cutoff for Magstream 55 ng/ml and for OC Sensor 150 ng/ml). Screening will be considered as positive if at least one of the three tests is positive, leading to a colonoscopy

Primary Outcome Measures

Name	Time	Method
Ratio of sensitivities (RSN) for detection of advanced neoplasias	Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)	Advanced neoplasias included invasive cancers and high-risk adenomas (larger than 1 cm or with high grade dysplasia).; RSN is the ratio of the true positives of two tests. True positives for one test are patients positive for the test, with targeted lesion (here advanced neoplasias).; RSN will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.

Secondary Outcome Measures

Name	Time	Method
Predictive value for detection of advanced neoplasias	Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of invasive cancer	Up to 6 months after FOBT (At the time of colonoscopy)
Positivity rate	Immediate (At the time of FOBT)
RFP for detection of advanced neoplasias	Up to 6 months after FOBT (At the time of colonoscopy)	RFP is related to specificity. False positives of one test are patients with a positive test but without targeted lesions (here advanced neoplasias).; RFP will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.
Relative Receiver Operating Characteristics(ROC) curves	Up to 6 months after FOBT (At the time of colonoscopy)	Relative ROC curves plots RSN according to RFP (similar to ROC curve). Relative ROC curves will be compared in reference to gaiac test, according to number of samples analysed for each immunochemical test, and the way they are analysed.
Cost-effectiveness analysis	Up to 6 months after FOBT (At the time of colonoscopy)	It will take into account number of samples and threshold
Ratio of False Positives (RFP) for detection of invasive cancers	Up to 6 months after FOBT (At the time of colonoscopy)	RFP is related to specificity. False positives of one test are patients with a positive test but without targeted lesions (here invasive cancers).; RFP will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.
Detection rate of advanced neoplasias	Up to 6 months after FOBT (At the time of colonoscopy)
Predictive positive value for detection of invasive cancers	Up to 6 months after FOBT (At the time of colonoscopy)

Trial Locations

Locations (2)

ADECA; 🇫🇷 Moulins, France

Adoc18 - Irsa; 🇫🇷 St Doulchard, France