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

Caen University Hospital

Status and phase: Unknown; Phase 3

Conditions: Lung Neoplasms

Treatments: Other: low-dose CT-scan AND induced sputum sample AND blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT01687647

PHRC11-221 (Other Grant/Funding Number)

2011-A01380-41

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 56+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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1,000 participants in 1 patient group

Screening

Other group

Description:

Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects.

Treatment:

Other: low-dose CT-scan AND induced sputum sample AND blood test