Lung NeoplasmsPhase 3AMORCE-CBPNCT01687647
Sputum Cytometry Analysis in Lung Cancer Screening After Professional Asbestos Exposure
A Phase 3 study testing low-dose CT-scan AND induced sputum sample AND blood test in people with Lung Neoplasms, run by University Hospital, Caen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- low-dose CT-scan AND induced sputum sample AND blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2012to 14 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Personal history of lung cancer
- Refusal of the study protocol
- Uncontrolled asthma or lung failure
Trial locations and contacts
3 sites in 1 country.
France3 sites
Caen University Hospital
Caen, 14000
Le Havre Hospital
Le Havre, 76600
Rouen University Hospital
Rouen, 76031
About this study
Official title: 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
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.
- Conditions
- Lung Neoplasms
- Being tested
- low-dose CT-scan AND induced sputum sample AND blood test
- Keywords
- Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Screening | Other | Paired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects. Receives: Other: low-dose CT-scan AND induced sputum sample AND blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of false positive
Ratio of false positives (RFP) for detection of lung cancer in reference to conventional cytology analysis of sputum
Measured: within 3 months
detection of lung cancer
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
Measured: within 3 months
Secondary outcomes (3)
Sensitivity for lung cancer detection compared with CT-scan
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.
Measured: within 3 months
Specificity for detection of lung cancer
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.
Measured: within 3 months
Predictive Biomarkers
Frequency of specific biomarkers at the time of screening. Links between lung cancer during 5 years of prospective follow-up.
Measured: Annually during a maximum of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Lydia GUITTET, MD,PhD, Study director, Caen University Hospital, INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687647
- Sponsor's protocol ID
- 2011-A01380-41
- Other IDs
- PHRC11-221
- Acronym
- AMORCE-CBP
- Status last verified
- Apr 2014
- First submitted
- 31 Aug 2012
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01687647
- Acronym / sponsor ID
- AMORCE-CBP / 2011-A01380-41
- Conditions
- Lung Neoplasms
- Keywords
- Lung cancer screening, Asbestos exposed workers, Sputum analysis, Automated cytometry, Predictive biomarkers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 463 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2012
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Other | Other: low-dose CT-scan AND induced sputum sample AND blood testPaired-design: low-dose CT scan, sputum sample and blood test will be performed on all subjects. |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Personal history of lung cancer
- Refusal of the study protocol
- Uncontrolled asthma or lung failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose CT-scan AND induced sputum sample AND blood testAll subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum | Other | Screening |
Primary outcome
Risk of false positive
Time frame: 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
Time frame: within 3 months
Ratio of sensitivities for detection of lung cancer in reference to conventionnal cytology analysis of sputum
3 secondary outcomes
Sensitivity for lung cancer detection compared with CT-scan
Time frame: within 3 months
Specificity for detection of lung cancer
Time frame: within 3 months
Predictive Biomarkers
Time frame: Annually during a maximum of 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia GUITTET, MD,PhD study director
Caen University Hospital, INSERM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low-dose CT-scan AND induced sputum sample AND blood test in people with Lung Neoplasms, run by University Hospital, Caen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of false positive (time frame: within 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.