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

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
low-dose CT-scan AND induced sputum sample AND blood test
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms focused on measuring Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers

Eligibility Criteria

56 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University Hospital
  • Le Havre Hospital
  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Screening

Arm Description

Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.

Outcomes

Primary Outcome Measures

Risk of false positive
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
detection of lung cancer
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
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
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
Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.

Full Information

First Posted
August 31, 2012
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01687647
Brief Title
Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure
Acronym
AMORCE-CBP
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening
Arm Type
Other
Arm Description
Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.
Intervention Type
Other
Intervention Name(s)
low-dose CT-scan AND induced sputum sample AND blood test
Intervention Description
All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
Primary Outcome Measure Information:
Title
Risk of false positive
Description
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
Time Frame
within 3 months
Title
detection of lung cancer
Description
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
Time Frame
within 3 months
Secondary Outcome Measure Information:
Title
Sensitivity for lung cancer detection compared with CT-scan
Description
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.
Time Frame
within 3 months
Title
Specificity for detection of lung cancer
Description
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.
Time Frame
within 3 months
Title
Predictive Biomarkers
Description
Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.
Time Frame
Annually during a maximum of 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia GUITTET, MD,PhD
Organizational Affiliation
Caen University Hospital, INSERM
Official's Role
Study Director
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Le Havre Hospital
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

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