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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:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01687647
First received: August 31, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Risk of false positive [ Time Frame: within 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01687647     History of Changes
Other Study ID Numbers: 2011-A01380-41, PHRC11-221
Study First Received: August 31, 2012
Last Updated: September 14, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Lung cancer screening
Asbestos exposed workers
Sputum analysis
Automated cytometry
Predictive biomarkers

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013