Lung CancerLUCSONCT03562052
Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens
An observational study of Lung Cancer, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.
Trial summary
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of… Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 6,000 participants
- Where
- 8 sitesFrance
- Study dates
- 22 Jul 2021to 31 Jul 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged from 55 to 74 years, current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. These subjects are known to be high-risk population for lung cancer.
Who may be able to join
- Subjects at high risk of lung cancer: current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. With an algorithm for determination of minimal duration of exposure to occupational carcinogens (according to the type and duration of occupational lung carcinogens)
Who cannot join
- Presence of clinical signs of lung cancer
- Subjects with a history of lung cancer
- Presence of serious short-term life-threatening comorbidities
- Absence of occupational exposure to lung carcinogens according to the predefined criteria
- Subjects already included in another prospective cohort study
- Subjects already assessed by chest CT scan during the previous year
- No tobacco exposure or insufficient tobacco exposure or smoking cessation for more than 15 years.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 7 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
Fleur Delva, MD, 557821684 ext. 0033, fleur.delva@chu-bordeaux.fr
Patrick Brochard, Pr
- Active, not recruiting
Université de Bordeaux
Bordeaux, 33076
- Not yet recruiting
Centre Hospitalier Universitaire de Brest
Brest, 29609
David LUCAS, Dr
Jean-Dominique Dewitte, MD
- Not yet recruiting
Centre Hospitalier Universitaire de Caen
Caen, 14033
Bénédicte Clin-Godart, Pr
Bénédicte Clin-Godart, Pr
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Jean-Claude Pairon, Pr, 157022093 ext. 0033, JC.Pairon@chicreteil.fr
Nadia Abdessemed, MD
- Not yet recruiting
Centre Hospitalier Universitaire de Rennes
Rennes, 35033
Christophe Paris, Pr
Christophe Paris, Pr
- Not yet recruiting
Centre Hospitalier Universitaire de Rouen
Rouen, 76032
Jean-François Gehanno, Pr
Antoine Gislard, MD
- Not yet recruiting
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
Olivier Bylicki, Dr
Olivier Bylicki, MD
About this study
Official title: LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
Read more
The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).
In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).
The trial will be conducted in several steps:
- Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
- Evaluation of occupational exposure to lung carcinogens
- Evaluation of the lung cancer risk level and verification of eligibility
- Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
- Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
Read the detailed description
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and the Recommendation R12 of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
The primary objective of this study is to evaluate the organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate
The secondary objectives of the study are:
- Describe the population recruited in each step of the protocol
- Develop a tool to identify subjects exposed to pulmonary carcinogens and with high-risk of lung cancer
- Evaluate the impact of the proposed screening programme on smoking cessation at one, two and three years.
- Evaluate the social impact of the screening campaign
- Conduct a cost-effectiveness analysis of the programme
The proposed study will take place in multidisciplinary and specialized reference centers (SRC) in various French districts participating in the programme, to welcome patients participating. It is organized into six workpackages (WP):
- WP1: Methodology - Epidemiology
- WP2: Evaluation of occupational exposure
- WP3: Imaging
- WP4: Lung cancer follow-up strategy
- WP5: Smoking cessation
- WP6: Medico-economic analysis Six specialized reference centers are proposed in four different regions in order to test a potential region effect and to allow the recruitment by each SRC of about 200 to 600 new eligible subjects per year and per department according to the population and the age pyramid of each department
- SRC1: Centre Intercommunal de Créteil for the Val-de-Marne (94), Seine-et-Marne (77), and Essonne (91) departments
- SRC2: Bordeaux University Hospital for the Gironde (33) department
- SRC3: Rennes University Hospital for the Ille-et-Vilaine (35) department
- SRC4: Brest University Hospital for the Finistère (29) department
- SRC5: Caen University Hospital for the Calvados (14) department
- SRC6: Rouen University Hospital for the Seine-Maritime (76) department
Each of these centers is voluntary and possesses the four essential prerequisites: an occupational health clinic - radiology team with specific skills in chest imaging - pulmonology team or network of pulmonologists specialized in lung cancer - smoking cessation team.
In view of the complexity of this organization, it is proposed to initially test the feasibility and acceptability of the screening programme sequentially for the first two years (24 months) in two SRCs (SRC1 and SRC2): "Phase 1: 2021-2023". It is expected to extend the study to the other SRCs after two years: "Phase 2: 2023-2029". Ad hoc adjustments will be decided for the creation of SRCs in the third year on the basis of the data acquired in the two pilot departments, especially on the expected target population participation rate. Mortality will be monitored at least until 2031.
The trial will be conducted in several steps:
- Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
- Evaluation of occupational exposure to lung carcinogens
- Evaluation of the lung cancer risk level and verification of eligibility
- Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
- Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
- Conditions
- Lung Cancer
- Keywords
- Cancer, Lung, Occupational carcinogens, Tobacco smoking, Screening, Chest CT Scan, Asbestos
- Medical subject headings
- Lung Neoplasms, Neoplasms, Tobacco Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of detected lung cancer
The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
Measured: Year 1
Secondary outcomes (67)
Rate of detected lung cancer
The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
Measured: Year 2
Rate of detected lung cancer
The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
Measured: Day 0
Participation rate
The proportion of subjects performing the low-dose chest CT scan among eligible responders during the first phase of the study
Measured: Day 0
Rate of detected lung cancer in subjects exposed to occupational carcinogens
The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
Measured: Day 0
Rate of detected lung cancer in subjects exposed to occupational carcinogens
The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
Measured: Year 1
Rate of detected lung cancer in subjects exposed to occupational carcinogens
The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
Measured: Year 2
Stage of detected lung cancers
Measured: Day 0
Stage of detected lung cancers
Measured: Year 1
Stage of detected lung cancers
Measured: Year 2
Smoking cessation rate obtained in smokers in the sreened population
The proportion of subjects with smoking cessation among smokers
Measured: Year 3
Mortality rate in the sreened population
Measured: Year 3
Mortality rate in the sreened population
Measured: Year 5
Mortality rate in the sreened population
Measured: Year 7
Mortality rate in the non-screened population
Measured: Year 3
Mortality rate in the non-screened population
Measured: Year 5
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Measured: Year 3
Mortality rate in the non-screened population
Measured: Year 7
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Measured: Year 5
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Measured: Year 7
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Measured: Year 3
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Measured: Year 5
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Measured: Year 7
Percentage of subjects participating in all screening (over the three years)
Measured: Year 3
Percentage of subjects participating in all screening (over the three years)
Measured: Year 4
Percentage of the subjects lost during follow-up in the screened population (follow-up at one year, two years, completion of other complementary exams)
Measured: Year 1
Percentage of the subjects lost during follow-up in the screened population (follow-up at one year, two years, completion of other complementary exams)
Measured: Year 2
Validity of the detailed personalised self-administered questionnaire for the evaluation of occupational exposures
Measured: Day 0
Number of cases recognized as occupational disease (for lung cancer or other occupational diseases)
Measured: Year 2
Proportion of invasive diagnostic procedures
Measured: Day 0
Proportion of invasive diagnostic procedures
Measured: Year 1
Proportion of invasive diagnostic procedures
Measured: Year 2
Proportion of non-invasive diagnostic procedures
Measured: Day 0
Proportion of non-invasive diagnostic procedures
Measured: Year 1
Proportion of non-invasive diagnostic procedures
Measured: Year 2
Proportion of serious and non-serious adverse events related to screening
Measured: Day 0
Proportion of serious and non-serious adverse events related to screening
Measured: Year 1
Proportion of serious and non-serious adverse events related to screening
Measured: Year 2
Proportion of subjects stopping smoking at each stage of screening
Measured: Day 0
Proportion of subjects stopping smoking at each stage of screening
Measured: Year 1
Proportion of subjects stopping smoking at each stage of screening
Measured: Year 2
The time period between each step of the screening (evaluation of the exposure, addressing in consultation of occupational diseases, inclusion, different exams of the follow-up)
Measured: Day 0
The time period between each step of the screening (evaluation of the exposure, addressing in consultation of occupational diseases, inclusion, different exams of the follow-up)
Measured: Year 1
The time period between each step of the screening (evaluation of the exposure, addressing in consultation of occupational diseases, inclusion, different exams of the follow-up)
Measured: Year 3
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Subject inclusion
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Year 1
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Year 2
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Year 3
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Year 4
Number of additional radiological examinations performed besides the prescribed CT scans of the protocol
Measured: Year 5
Number of hospitalizations
Measured: Subject inclusion
Number of hospitalizations
Measured: Year 1
Number of hospitalizations
Measured: Year 2
Number of hospitalizations
Measured: Year 3
Number of hospitalizations
Measured: Year 4
Number of hospitalizations
Measured: Year 5
Number of lung surgery
Measured: Subject inclusion
Number of lung surgery
Measured: Year 1
Number of lung surgery
Measured: Year 2
Number of lung surgery
Measured: Year 3
Number of lung surgery
Measured: Year 4
Number of lung surgery
Measured: Year 5
Number of chemotherapy
Measured: Day 0
Number of chemotherapy
Measured: Year 1
Number of chemotherapy
Measured: Year 2
Number of chemotherapy
Measured: Year 3
Number of chemotherapy
Measured: Year 4
Number of chemotherapy
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start22 Jul 2021
- Primary completionJul 2026 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, Rennes University Hospital, Centre Hospitalier Régional et Universitaire de Brest, University Hospital, Caen, University Hospital, Rouen, Direction Centrale du Service de Santé des Armées
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Pairon, Pr, Principal investigator, Centre Hospitalier Interconnmunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562052
- Sponsor's protocol ID
- LUCSO
- Acronym
- LUCSO
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2018
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaid C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pelissier S, Pairon JC. LUCSO-1-French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol. BMJ Open. 2019 Mar 23;9(3):e025026. doi: 10.1136/bmjopen-2018-025026.
PubMed 30904859
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens
- ClinicalTrials.gov ID
- NCT03562052
- Acronym / sponsor ID
- LUCSO / LUCSO
- Conditions
- Lung Cancer
- Keywords
- Cancer, Lung, Occupational carcinogens, Tobacco smoking, Screening, Chest CT Scan, Asbestos
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, Rennes University Hospital, Centre Hospitalier Régional et Universitaire de Brest, University Hospital, Caen, University Hospital, Rouen, Direction Centrale du Service de Santé des Armées
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 19 Jun 2018 (actual)
- 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.
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).
In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).
The trial will be conducted in several steps:
- Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
- Evaluation of occupational exposure to lung carcinogens
- Evaluation of the lung cancer risk level and verification of eligibility
- Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
- Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
Detailed description
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and the Recommendation R12 of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).
In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.
The primary objective of this study is to evaluate the organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:
- Screening activity indicator: screening coverage rate over two years
- Test quality indicator: validity of self-administered questionnaires to target the high-risk population
- Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
- Follow-up indicator: smoking cessation rate, mortality rate
The secondary objectives of the study are:
- Describe the population recruited in each step of the protocol
- Develop a tool to identify subjects exposed to pulmonary carcinogens and with high-risk of lung cancer
- Evaluate the impact of the proposed screening programme on smoking cessation at one, two and three years.
- Evaluate the social impact of the screening campaign
- Conduct a cost-effectiveness analysis of the programme
The proposed study will take place in multidisciplinary and specialized reference centers (SRC) in various French districts participating in the programme, to welcome patients participating. It is organized into six workpackages (WP):
- WP1: Methodology - Epidemiology
- WP2: Evaluation of occupational exposure
- WP3: Imaging
- WP4: Lung cancer follow-up strategy
- WP5: Smoking cessation
- WP6: Medico-economic analysis Six specialized reference centers are proposed in four different regions in order to test a potential region effect and to allow the recruitment by each SRC of about 200 to 600 new eligible subjects per year and per department according to the population and the age pyramid of each department
- SRC1: Centre Intercommunal de Créteil for the Val-de-Marne (94), Seine-et-Marne (77), and Essonne (91) departments
- SRC2: Bordeaux University Hospital for the Gironde (33) department
- SRC3: Rennes University Hospital for the Ille-et-Vilaine (35) department
- SRC4: Brest University Hospital for the Finistère (29) department
- SRC5: Caen University Hospital for the Calvados (14) department
- SRC6: Rouen University Hospital for the Seine-Maritime (76) department
Each of these centers is voluntary and possesses the four essential prerequisites: an occupational health clinic - radiology team with specific skills in chest imaging - pulmonology team or network of pulmonologists specialized in lung cancer - smoking cessation team.
In view of the complexity of this organization, it is proposed to initially test the feasibility and acceptability of the screening programme sequentially for the first two years (24 months) in two SRCs (SRC1 and SRC2): "Phase 1: 2021-2023". It is expected to extend the study to the other SRCs after two years: "Phase 2: 2023-2029". Ad hoc adjustments will be decided for the creation of SRCs in the third year on the basis of the data acquired in the two pilot departments, especially on the expected target population participation rate. Mortality will be monitored at least until 2031.
The trial will be conducted in several steps:
- Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
- Evaluation of occupational exposure to lung carcinogens
- Evaluation of the lung cancer risk level and verification of eligibility
- Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
- Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged from 55 to 74 years, current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. These subjects are known to be high-risk population for lung cancer.
Key inclusion criteria (1 listed)
- Subjects at high risk of lung cancer: current smokers smoking 30 pack-years or more or ex-smokers smoking 30 pack-years or more and who have quit smoking for less than 15 years and currently or previously occupationally exposed to lung carcinogens. With an algorithm for determination of minimal duration of exposure to occupational carcinogens (according to the type and duration of occupational lung carcinogens)
Key exclusion criteria (7 listed)
- Presence of clinical signs of lung cancer
- Subjects with a history of lung cancer
- Presence of serious short-term life-threatening comorbidities
- Absence of occupational exposure to lung carcinogens according to the predefined criteria
- Subjects already included in another prospective cohort study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of detected lung cancer
Time frame: Year 1
The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
67 secondary outcomes
Rate of detected lung cancer
Time frame: Year 2
Rate of detected lung cancer
Time frame: Day 0
Participation rate
Time frame: Day 0
Rate of detected lung cancer in subjects exposed to occupational carcinogens
Time frame: Day 0
Rate of detected lung cancer in subjects exposed to occupational carcinogens
Time frame: Year 1
Rate of detected lung cancer in subjects exposed to occupational carcinogens
Time frame: Year 2
Stage of detected lung cancers
Time frame: Day 0
Stage of detected lung cancers
Time frame: Year 1
Stage of detected lung cancers
Time frame: Year 2
Smoking cessation rate obtained in smokers in the sreened population
Time frame: Year 3
Mortality rate in the sreened population
Time frame: Year 3
Mortality rate in the sreened population
Time frame: Year 5
Mortality rate in the sreened population
Time frame: Year 7
Mortality rate in the non-screened population
Time frame: Year 3
Mortality rate in the non-screened population
Time frame: Year 5
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Time frame: Year 3
Mortality rate in the non-screened population
Time frame: Year 7
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Time frame: Year 5
Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center
Time frame: Year 7
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Time frame: Year 3
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Time frame: Year 5
Rate of detected lung cancer and stage of detected lung cancer in the non-screened population
Time frame: Year 7
Percentage of subjects participating in all screening (over the three years)
Time frame: Year 3
Percentage of subjects participating in all screening (over the three years)
Time frame: Year 4
Percentage of the subjects lost during follow-up in the screened population (follow-up at one year, two years, completion of other complementary exams)
Time frame: Year 1
Percentage of the subjects lost during follow-up in the screened population (follow-up at one year, two years, completion of other complementary exams)
Time frame: Year 2
Validity of the detailed personalised self-administered questionnaire for the evaluation of occupational exposures
Time frame: Day 0
Number of cases recognized as occupational disease (for lung cancer or other occupational diseases)
Time frame: Year 2
Proportion of invasive diagnostic procedures
Time frame: Day 0
Proportion of invasive diagnostic procedures
Time frame: Year 1
Proportion of invasive diagnostic procedures
Time frame: Year 2
Proportion of non-invasive diagnostic procedures
Time frame: Day 0
Proportion of non-invasive diagnostic procedures
Time frame: Year 1
Proportion of non-invasive diagnostic procedures
Time frame: Year 2
Proportion of serious and non-serious adverse events related to screening
Time frame: Day 0
Proportion of serious and non-serious adverse events related to screening
Time frame: Year 1
Proportion of serious and non-serious adverse events related to screening
Time frame: Year 2
Proportion of subjects stopping smoking at each stage of screening
Time frame: Day 0
Proportion of subjects stopping smoking at each stage of screening
Time frame: Year 1
Proportion of subjects stopping smoking at each stage of screening
Time frame: Year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 30904859Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaid C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pelissier S, Pairon JC. LUCSO-1-French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol. BMJ Open. 2019 Mar 23;9(3):e025026. doi: 10.1136/bmjopen-2018-025026.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Jean-Claude Pairon, Pr principal investigator
Centre Hospitalier Interconnmunal de Créteil
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Centre Hospitalier Intercommunal Creteil at 8 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Claude Pairon, Pr (157022093 ext. 0033, JC.Pairon@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of detected lung cancer (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562052, which also lists 1 linked publication.
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 9 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.