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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute, France
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01251666
First received: November 29, 2010
Last updated: August 31, 2012
Last verified: August 2012
History of Changes

November 29, 2010
August 31, 2012
June 2008
June 2012   (final data collection date for primary outcome measure)
Ratio of sensitivities (RSN) for detection of advanced neoplasias [ Time Frame: Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy) ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01251666 on ClinicalTrials.gov Archive Site
  • Ratio of False Positives (RFP) for detection of invasive cancers [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: Yes ]

    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.

  • RFP for detection of advanced neoplasias [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: Yes ]

    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.

  • Relative Receiver Operating Characteristics(ROC) curves [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
    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.
  • Detection rate of invasive cancer [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
  • Detection rate of advanced neoplasias [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
  • Cost-effectiveness analysis [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
    It will take into account number of samples and threshold
  • Predictive positive value for detection of invasive cancers [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
  • Predictive value for detection of advanced neoplasias [ Time Frame: Up to 6 months after FOBT (At the time of colonoscopy) ] [ Designated as safety issue: No ]
  • Positivity rate [ Time Frame: Immediate (At the time of FOBT) ] [ Designated as safety issue: No ]
Same as current
 
 
 
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

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.
 
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Colorectal Cancer
Other: Colonoscopy
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
Magstream + Oc Sensor + Hemoccult II

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

Intervention: Other: Colonoscopy
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19797
August 2012
June 2012   (final data collection date for primary outcome measure)

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)
Both
50 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01251666
2008-A01463-52
No
University Hospital, Caen
University Hospital, Caen
  • National Cancer Institute, France
  • Ligue contre le cancer, France
Study Director: Guy LAUNOY, MD-PhD University Hospital, Caen
University Hospital, Caen
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP