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: April 8, 2014
Last verified: April 2014

August 31, 2012
April 8, 2014
September 2012
March 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01687647 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Lung Neoplasms
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
Screening
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
Intervention: Other: low-dose CT-scan AND induced sputum sample AND blood test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
December 2019
March 2015   (final data collection date for primary outcome measure)

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
Both
56 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01687647
2011-A01380-41, PHRC11-221
No
University Hospital, Caen
University Hospital, Caen
Ministry of Health, France
Study Director: Lydia GUITTET, MD,PhD Caen University Hospital, INSERM
University Hospital, Caen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP