Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

Phase 3

• Conditions: Lung Neoplasms
• Interventions: Other: low-dose CT-scan AND induced sputum sample AND blood test

• Registration Number: NCT01687647
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-31
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09
• Primary Completion: 2015-03
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening	low-dose CT-scan AND induced sputum sample AND blood test	Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.

Primary Outcome Measures

Name	Time	Method
Risk of false positive	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	within 3 months	Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum

Secondary Outcome Measures

Name	Time	Method
Sensitivity for lung cancer detection compared with CT-scan	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	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	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.

Trial Locations

Locations (3)

Rouen University Hospital; 🇫🇷 Rouen, France

Caen University Hospital; 🇫🇷 Caen, France

Le Havre Hospital; 🇫🇷 Le Havre, France