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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01687647 |
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Date of registration:
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31/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure
AMORCE-CBP |
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Scientific title:
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Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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1000 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01687647 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Lydia GUITTET, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Caen University Hospital, INSERM |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- High professional asbestos exposure
- Member of a former cohort recruited between 2000 and 2006 in Caen, Rouen and Le Havre
(inclusion criteria: 50-75 years at the time of initial recruitment, high
intermittent asbestos exposure >= 1 year, or high discontinuous asbestos exposure
>=10 years). All the living members of the cohort will be contacted: a maximum of
1000 subjects is expected, probably less.
- Informed consent signed
Exclusion Criteria:
- Personal history of lung cancer
- Refusal of the study protocol
- Uncontrolled asthma or lung failure
Age minimum:
56 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Neoplasms
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Intervention(s)
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Other: low-dose CT-scan AND induced sputum sample AND blood test
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Primary Outcome(s)
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Risk of false positive
[Time Frame: within 3 months]
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detection of lung cancer
[Time Frame: within 3 months]
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Secondary Outcome(s)
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Specificity for detection of lung cancer
[Time Frame: within 3 months]
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Predictive Biomarkers
[Time Frame: Annually during a maximum of 5 years]
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Sensitivity for lung cancer detection compared with CT-scan
[Time Frame: within 3 months]
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Secondary ID(s)
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2011-A01380-41
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PHRC11-221
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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