Clinical trial NCT01251666: Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
Official title: Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Screening
Average-risk population
faecal occult blood tests
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Ligue contre le cancer, France
First posted: 2010-12-02
Enrollment: 19797
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Ratio of sensitivities (RSN) for detection of advanced neoplasias
timeFrame: Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Secondary outcomes:
measure: Ratio of False Positives (RFP) for detection of invasive cancers
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: RFP for detection of advanced neoplasias
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Relative Receiver Operating Characteristics(ROC) curves
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Detection rate of invasive cancer
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Detection rate of advanced neoplasias
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Cost-effectiveness analysis
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Predictive positive value for detection of invasive cancers
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Predictive value for detection of advanced neoplasias
timeFrame: Up to 6 months after FOBT (At the time of colonoscopy)
measure: Positivity rate
timeFrame: Immediate (At the time of FOBT)
Other outcomes:
Locations:
city: Moulins
country: France
facility: ADECA
city: St Doulchard
country: France
facility: Adoc18 - Irsa
Study officials:
affiliation: University Hospital, Caen
name: Guy LAUNOY, MD-PhD
role: STUDY_DIRECTOR
References:
citation: Raginel T, Puvinel J, Ferrand O, Bouvier V, Levillain R, Ruiz A, Lantieri O, Launoy G, Guittet L. A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening. Gastroenterology. 2013 May;144(5):918-25. doi: 10.1053/j.gastro.2013.01.042. Epub 2013 Feb 1.