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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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Other: Colonoscopy
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Enrollment: 19797
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 Other: Colonoscopy
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251666

Locations
France
ADECA
Moulins, France, 03007
Adoc18 - Irsa
St Doulchard, France, 18230
Sponsors and Collaborators
University Hospital, Caen
National Cancer Institute, France
Ligue contre le cancer, France
Investigators
Study Director: Guy LAUNOY, MD-PhD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01251666     History of Changes
Other Study ID Numbers: 2008-A01463-52
Study First Received: November 29, 2010
Last Updated: August 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Colorectal cancer
Screening
Average-risk population
faecal occult blood tests

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013