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: September 14, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2012

Last Updated Date

September 14, 2012

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01687647 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Lung Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

December 2019

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

56 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01687647

Other Study ID Numbers ^ICMJE

2011-A01380-41, PHRC11-221

Has Data Monitoring Committee

Responsible Party

University Hospital, Caen

Study Sponsor ^ICMJE

University Hospital, Caen

Collaborators ^ICMJE

Ministry of Health, France

Investigators ^ICMJE

Study Director:

Lydia GUITTET, MD,PhD

Caen University Hospital, INSERM

Information Provided By

University Hospital, Caen

Verification Date

September 2012

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

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