A Phase 3 interventional study of Colonoscopy in Colorectal Cancer, sponsored by University Hospital, Caen. Completed at 2 sites in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-09-03.
Sponsored by University Hospital, Caen · Phase 3, Interventional, and Screening
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 19,797 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
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
Other: Colonoscopy
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
Ratio of sensitivities (RSN) for detection of advanced neoplasias
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.
Time frame: Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Ratio of False Positives (RFP) for detection of invasive cancers
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.
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
RFP for detection of advanced neoplasias
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.
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Relative Receiver Operating Characteristics(ROC) curves
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.
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of invasive cancer
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of advanced neoplasias
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Cost-effectiveness analysis
It will take into account number of samples and threshold
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive positive value for detection of invasive cancers
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive value for detection of advanced neoplasias
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Positivity rate
Time frame: Immediate (At the time of FOBT)
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen