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

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Other: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01251666

2008-A01463-52

Details and patient eligibility

About

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.

Enrollment: 19,797 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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19,797 participants in 1 patient group

Magstream + Oc Sensor + Hemoccult II

Other group

Description:

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

Treatment:

Other: Colonoscopy