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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms
• Intervention / Treatment: Other: low-dose CT-scan AND induced sputum sample AND blood test

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CAEN University Hospital
  • Le Havre, France, 76600
    • Le Havre Hospital
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of false positive	Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum	within 3 months
detection of lung cancer	Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum	within 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 3 months
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.	within 3 months
Predictive Biomarkers	Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.	Annually during a maximum of 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Ministry of Health, France
• Investigators: Study Director: Lydia GUITTET, MD,PhD, Caen University Hospital, INSERM

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Lung cancer screening; Predictive biomarkers; Asbestos exposed workers; Sputum analysis; Automated cytometry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2011-A01380-41; PHRC11-221 (Other Grant/Funding Number: French Ministry of Health (DGOS))