Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
HeMO
Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
1 other identifier
interventional
19,797
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jun 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 3, 2012
August 1, 2012
4 years
November 29, 2010
August 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (9)
Ratio of False Positives (RFP) for detection of invasive cancers
Up to 6 months after FOBT (At the time of colonoscopy)
RFP for detection of advanced neoplasias
Up to 6 months after FOBT (At the time of colonoscopy)
Relative Receiver Operating Characteristics(ROC) curves
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)
- +4 more secondary outcomes
Study Arms (1)
Magstream + Oc Sensor + Hemoccult II
OTHEREach 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
Interventions
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
Eligibility Criteria
You may qualify if:
- to 74 years
- Informed consent signed
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- National Cancer Institute, Francecollaborator
- Ligue contre le cancer, Francecollaborator
Study Sites (2)
ADECA
Moulins, 03007, France
Adoc18 - Irsa
Saint-Doulchard, 18230, France
Related Publications (1)
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.
PMID: 23376426DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guy LAUNOY, MD-PhD
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2010
First Posted
December 2, 2010
Study Start
June 1, 2008
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
September 3, 2012
Record last verified: 2012-08