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Note: This record shows only 21 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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01687647
Date of registration: 31/08/2012
Prospective Registration: Yes
Primary sponsor: University Hospital, Caen
Public title: Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure AMORCE-CBP
Scientific title: 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
Date of first enrolment: September 2012
Target sample size: 1000
Recruitment status: Enrolling by invitation
URL:  http://clinicaltrials.gov/show/NCT01687647
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Lydia GUITTET, MD,PhD
Address: 
Telephone:
Email:
Affiliation:  Caen University Hospital, INSERM
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Lung Neoplasms
Intervention(s)
Other: low-dose CT-scan AND induced sputum sample AND blood test
Primary Outcome(s)
detection of lung cancer [Time Frame: within 3 months]
Risk of false positive [Time Frame: within 3 months]
Secondary Outcome(s)
Predictive Biomarkers [Time Frame: Annually during a maximum of 5 years]
Sensitivity for lung cancer detection compared with CT-scan [Time Frame: within 3 months]
Specificity for detection of lung cancer [Time Frame: within 3 months]
Secondary ID(s)
2011-A01380-41
PHRC11-221
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, France
Results
Results available:
Date Posted:
URL:
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