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Completed

NCT Number: NCT01251666

Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ADECA, Moulins, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

colonoscopy

Other

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

Primary outcomes

  1. 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)

    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 outcomes

  1. Ratio of False Positives (RFP) for detection of invasive cancers

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

    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.

  2. RFP for detection of advanced neoplasias

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

    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.

  3. Relative Receiver Operating Characteristics(ROC) curves

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

    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.

  4. Detection rate of invasive cancer

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

  5. Detection rate of advanced neoplasias

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

  6. Cost-effectiveness analysis

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

    It will take into account number of samples and threshold

  7. Predictive positive value for detection of invasive cancers

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

  8. Predictive value for detection of advanced neoplasias

    Time frame: Up to 6 months after FOBT (At the time of colonoscopy)

  9. Positivity rate

    Time frame: Immediate (At the time of FOBT)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Ligue contre le cancer, France
  • National Cancer Institute, France

Registry information

Official study title

Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

Acronym: HeMO

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2010
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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