NCT01251666

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

Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19,797 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Colonoscopy	Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2010-12-02
• Last updated: 2012-09-03

Locations

2 sites across 1 country: France