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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687647
First Posted: September 19, 2012
Last Update Posted: April 9, 2014
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.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Caen
  Purpose

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 Intervention Phase
Lung Neoplasms Other: low-dose CT-scan AND induced sputum sample AND blood test Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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

  • 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:
  • 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.


  • 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.


  • 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.


Estimated Enrollment: 1000
Study Start Date: September 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Screening
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01687647


Locations
France
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
Investigators
Study Director: Lydia GUITTET, MD,PhD Caen University Hospital, INSERM
  More Information

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01687647     History of Changes
Other Study ID Numbers: 2011-A01380-41
PHRC11-221 ( Other Grant/Funding Number: French Ministry of Health (DGOS) )
First Submitted: August 31, 2012
First Posted: September 19, 2012
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:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases