Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure

NCT ID: NCT01687647

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Screening

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

Group Type OTHER

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

Intervention Type OTHER

All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* High professional asbestos exposure
* Informed consent signed

Exclusion Criteria

* Personal history of lung cancer
* Refusal of the study protocol
* Uncontrolled asthma or lung failure
Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lydia GUITTET, MD,PhD

Role: STUDY_DIRECTOR

Caen University Hospital, INSERM

Locations

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Caen University Hospital

Caen, , France

Site Status

Le Havre Hospital

Le Havre, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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PHRC11-221

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-A01380-41

Identifier Type: -

Identifier Source: org_study_id

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