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Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure (AMORCE-CBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687647
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Enrolling by invitation
First Posted : September 19, 2012
Last Update Posted : April 9, 2014
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.

An ancillary study will evaluate the interest of blood predictive biomarkers.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Other: low-dose CT-scan AND induced sputum sample AND blood test Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official 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
Study Start Date : September 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
Other: low-dose CT-scan AND induced sputum sample AND blood test
All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum

Primary Outcome Measures :
  1. Risk of false positive [ Time Frame: within 3 months ]
    Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum

  2. detection of lung cancer [ Time Frame: within 3 months ]
    Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum

Secondary Outcome Measures :
  1. Sensitivity for lung cancer detection compared with CT-scan [ Time Frame: within 3 months ]

    Ratio of sensitivity (RSN) for lung cancer detection in reference with CT scan.

    Interest of the combination "cytometry + CT-scan" compared with CT-scan alone will also be evaluated.

  2. Specificity for detection of lung cancer [ Time Frame: within 3 months ]

    Ratio of false positives (RFP) of automated cytometry analysis compared with CT-scan screening.

    The combination "automated cytometry + CTscan" will also be evaluated compared with CT scan alone.

  3. Predictive Biomarkers [ Time Frame: Annually during a maximum of 5 years ]
    Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01687647

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Caen University Hospital
Caen, France, 14000
Le Havre Hospital
Le Havre, France, 76600
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Caen
Ministry of Health, France
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Study Director: Lydia GUITTET, MD,PhD Caen University Hospital, INSERM
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Responsible Party: University Hospital, Caen Identifier: NCT01687647    
Other Study ID Numbers: 2011-A01380-41
PHRC11-221 ( Other Grant/Funding Number: French Ministry of Health (DGOS) )
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by University Hospital, Caen:
Lung cancer screening
Asbestos exposed workers
Sputum analysis
Automated cytometry
Predictive biomarkers
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases