NCT01687647

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

May 29, 2026

Status Verified

April 1, 2014

Enrollment Period

8.1 years

First QC Date

August 31, 2012

Last Update Submit

May 27, 2026

Conditions

Lung Neoplasms

Keywords

Lung cancer screeningAsbestos exposed workersSputum analysisAutomated cytometryPredictive biomarkers

Outcome Measures

Primary Outcomes (2)

  • 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

  • detection of lung cancer

    Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum

    within 3 months

Secondary Outcomes (3)

  • Sensitivity for lung cancer detection compared with CT-scan

    within 3 months

  • Specificity for detection of lung cancer

    within 3 months

  • Predictive Biomarkers

    Annually during a maximum of 5 years

Study Arms (1)

Screening

OTHER

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

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

Interventions

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

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

Screening

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High professional asbestos exposure
  • Informed consent signed

You may not qualify if:

  • Personal history of lung cancer
  • Refusal of the study protocol
  • Uncontrolled asthma or lung failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Caen University Hospital

Caen, 14000, France

Location

Le Havre Hospital

Le Havre, 76600, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Lydia GUITTET, MD,PhD

    Caen University Hospital, INSERM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 19, 2012

Study Start

September 1, 2012

Primary Completion

October 14, 2020

Study Completion

October 14, 2020

Last Updated

May 29, 2026

Record last verified: 2014-04

Locations

FR(3)