Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687647

Acronym

AMORCE-CBP

Enrollment

463

Registered

2012-09-19

Start date

2012-09-01

Completion date

2020-10-14

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers

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.

Interventions

OTHERlow-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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

56 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Contacts

STUDY_DIRECTORLydia GUITTET, MD,PhD

Caen University Hospital, INSERM

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026