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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| Ligue contre le cancer, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magstream + Oc Sensor + Hemoccult II | Other | Each patient will perform all three tests:
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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Other | Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months after FOBT (At the time of colonoscopy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy LAUNOY, MD-PhD | University Hospital, Caen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADECA | Moulins | 03007 | France | |||
| Adoc18 - Irsa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23376426 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. | 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. | 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) |
| Detection rate of advanced neoplasias | Up to 6 months after FOBT (At the time of colonoscopy) |
| Cost-effectiveness analysis | It will take into account number of samples and threshold | 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) |
| Predictive value for detection of advanced neoplasias | Up to 6 months after FOBT (At the time of colonoscopy) |
| Positivity rate | Immediate (At the time of FOBT) |
| Saint-Doulchard |
| 18230 |
| France |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |