Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

Lung Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01687647
• Other study ID #: 2011-A01380-41
• Secondary ID: PHRC11-221
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: August 31, 2012
• Last updated: April 8, 2014
• Start date: September 2012
• Est. completion date: December 2019

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Le Havre Hospital	Le Havre
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	detection of lung cancer	Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum	within 3 months	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No