Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening (HeMO)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer, Screening, Average-risk population, faecal occult blood tests
Eligibility 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)
Sites / Locations
- ADECA
- Adoc18 - Irsa
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Magstream + Oc Sensor + Hemoccult II
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Ratio of False Positives (RFP) for detection of invasive cancers
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
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
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
Detection rate of advanced neoplasias
Cost-effectiveness analysis
It will take into account number of samples and threshold
Predictive positive value for detection of invasive cancers
Predictive value for detection of advanced neoplasias
Positivity rate
Full Information
NCT ID
NCT01251666
First Posted
November 29, 2010
Last Updated
August 31, 2012
Sponsor
University Hospital, Caen
Collaborators
National Cancer Institute, France, Ligue contre le cancer, France
1. Study Identification
Unique Protocol Identification Number
NCT01251666
Brief Title
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
Acronym
HeMO
Official Title
Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
National Cancer Institute, France, Ligue contre le cancer, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Screening, Average-risk population, faecal occult blood tests
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
19797 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magstream + Oc Sensor + Hemoccult II
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Colonoscopy
Intervention Description
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
Primary Outcome Measure Information:
Title
Ratio of sensitivities (RSN) for detection of advanced neoplasias
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.
Time Frame
Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Secondary Outcome Measure Information:
Title
Ratio of False Positives (RFP) for detection of invasive cancers
Description
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.
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
RFP for detection of advanced neoplasias
Description
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.
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Relative Receiver Operating Characteristics(ROC) curves
Description
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.
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Detection rate of invasive cancer
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Detection rate of advanced neoplasias
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Cost-effectiveness analysis
Description
It will take into account number of samples and threshold
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Predictive positive value for detection of invasive cancers
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Predictive value for detection of advanced neoplasias
Time Frame
Up to 6 months after FOBT (At the time of colonoscopy)
Title
Positivity rate
Time Frame
Immediate (At the time of FOBT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy LAUNOY, MD-PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
ADECA
City
Moulins
ZIP/Postal Code
03007
Country
France
Facility Name
Adoc18 - Irsa
City
St Doulchard
ZIP/Postal Code
18230
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23376426
Citation
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.
Results Reference
derived
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Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
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