Suspended

AMORCE-CBPMorphometric Analysis of Sputum Cytology and Biomarkers for Lung Cancer Screening in Asbestos-Exposed Workers

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Study Aim

This study aims to evaluate the effectiveness and accuracy of morphometric analysis and biomarkers in sputum cytology for lung cancer screening in workers exposed to asbestos, comparing it to traditional methods.

What is being tested

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

Other
Who is being recruted

Lung Diseases+4

+ Neoplasms

+ Neoplasms by Site

Over 56 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Phase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Caen
Last updated: May 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on workers who have been highly exposed to asbestos, a group at high risk for lung cancer. Currently, these workers undergo repeated CT-scans for medical follow-ups, which are more effective at detecting peripheral lesions but expose individuals to radiation and risk of false-positives. The study aims to explore the potential benefits of analyzing sputum using automated cytometry, either alone or combined with CT-scans, to improve lung cancer screening in this population. The study also includes an ancillary study to evaluate the potential of blood predictive biomarkers for lung cancer. Participants in this study will provide sputum samples for analysis using automated cytometry, a method that examines cells in the sputum. The study measures the sensitivity of this method for detecting lung cancer compared to conventional cytology analysis of sputum. Additionally, the study evaluates the risk of false-positives for lung cancer detection using this method in comparison to conventional cytology analysis. The ancillary study involves blood tests to assess potential predictive biomarkers for lung cancer.

NCT01687647
Principal SponsorUniversity Hospital, Caen
Last updated: May 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

463 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 56 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung Neoplasms

Criteria

3 inclusion criteria required to participate
High professional asbestos exposure

Informed consent signed

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

3 exclusion criteria prevent from participating
Personal history of lung cancer

Refusal of the study protocol

Uncontrolled asthma or lung failure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Caen University Hospital

Caen, FranceOpen Caen University Hospital in Google Maps

Le Havre Hospital

Le Havre, France

Rouen University Hospital

Rouen, France
Suspended3 Study Centers