Colorectal CancerPhase 3HeMONCT01251666
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening
A Phase 3 study testing Colonoscopy in people with Colorectal Cancer, run by University Hospital, Caen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,797 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2008to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 to 74 years
- Informed consent signed
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy
- Keywords
- Colorectal cancer, Screening, Average-risk population, faecal occult blood tests
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyOther
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
| Study group | Role | What they receive |
|---|---|---|
| Magstream + Oc Sensor + Hemoccult II | Other | 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 Receives: Other: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
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.
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
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.
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of invasive cancer
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of advanced neoplasias
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Cost-effectiveness analysis
It will take into account number of samples and threshold
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive positive value for detection of invasive cancers
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive value for detection of advanced neoplasias
Measured: Up to 6 months after FOBT (At the time of colonoscopy)
Positivity rate
Measured: Immediate (At the time of FOBT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19,797 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Guy LAUNOY, MD-PhD, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251666
- Sponsor's protocol ID
- 2008-A01463-52
- Acronym
- HeMO
- Status last verified
- Aug 2012
- First submitted
- 29 Nov 2010
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23376426
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
- ClinicalTrials.gov ID
- NCT01251666
- Acronym / sponsor ID
- HeMO / 2008-A01463-52
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Screening, Average-risk population, faecal occult blood tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,797 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France
- Study start
- Jun 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magstream + Oc Sensor + Hemoccult II | Other | Other: ColonoscopyEach 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 |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 to 74 years
- Informed consent signed
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyColonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result) | Other | Magstream + Oc Sensor + Hemoccult II |
Primary outcome
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.
9 secondary outcomes
Ratio of False Positives (RFP) for detection of invasive cancers
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
RFP for detection of advanced neoplasias
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Relative Receiver Operating Characteristics(ROC) curves
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of invasive cancer
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Detection rate of advanced neoplasias
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Cost-effectiveness analysis
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive positive value for detection of invasive cancers
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Predictive value for detection of advanced neoplasias
Time frame: Up to 6 months after FOBT (At the time of colonoscopy)
Positivity rate
Time frame: Immediate (At the time of FOBT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Derived from this study: PubMed 23376426Raginel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy LAUNOY, MD-PhD study director
University Hospital, Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colonoscopy in people with Colorectal Cancer, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.