Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
50 Years
74 Years
Both
Colorectal Cancer
Trial Information
Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
Outcome Measure:
Ratio of sensitivities (RSN) for detection of advanced neoplasias
Outcome Description:
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.
Outcome Time Frame:
Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Safety Issue:
No
Principal Investigator
Guy LAUNOY, MD-PhD
Investigator Role:
Study Director
Investigator Affiliation:
University Hospital, Caen
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2008-A01463-52
NCT ID:
NCT01251666
Start Date:
June 2008
Completion Date:
August 2012
Related Keywords:
- Colorectal Cancer
- Colorectal cancer
- Screening
- Average-risk population
- faecal occult blood tests
- Colorectal Neoplasms
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