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RecruitingNCT03562052LUCSOUpdated Jul 9, 2024

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

An observational study in Lung Cancer, sponsored by Centre Hospitalier Intercommunal Creteil. Recruiting at 8 sites in France. Open to participants aged 55 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Centre Hospitalier Intercommunal Creteil · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
55 Years to 74 Years
Sex
All
01

Study 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 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:

  1. 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.
  2. Evaluation of occupational exposure to lung carcinogens
  3. Evaluation of the lung cancer risk level and verification of eligibility
  4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
  5. 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:

  1. 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.
  2. Evaluation of occupational exposure to lung carcinogens
  3. Evaluation of the lung cancer risk level and verification of eligibility
  4. Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
  5. Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.
02

Conditions studied

  • Lung Cancer

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Keywords

  • Cancer
  • Lung
  • Occupational carcinogens
  • Tobacco smoking
  • Screening
  • Chest CT Scan
  • Asbestos
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Rate of detected lung cancer

    The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

    Time frame: Year 1

Secondary outcomes

  1. Rate of detected lung cancer

    The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

    Time frame: Year 2

  2. Rate of detected lung cancer

    The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan

    Time frame: Day 0

  3. Participation rate

    The proportion of subjects performing the low-dose chest CT scan among eligible responders during the first phase of the study

    Time frame: Day 0

  4. 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

    Time frame: Day 0

  5. 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

    Time frame: Year 1

  6. 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

    Time frame: Year 2

  7. Stage of detected lung cancers

    Time frame: Day 0

  8. Stage of detected lung cancers

    Time frame: Year 1

  9. Stage of detected lung cancers

    Time frame: Year 2

  10. Smoking cessation rate obtained in smokers in the sreened population

    The proportion of subjects with smoking cessation among smokers

    Time frame: Year 3

  11. Mortality rate in the sreened population

    Time frame: Year 3

  12. Mortality rate in the sreened population

    Time frame: Year 5

  13. Mortality rate in the sreened population

    Time frame: Year 7

  14. Mortality rate in the non-screened population

    Time frame: Year 3

  15. Mortality rate in the non-screened population

    Time frame: Year 5

  16. Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center

    Time frame: Year 3

  17. Mortality rate in the non-screened population

    Time frame: Year 7

  18. Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center

    Time frame: Year 5

  19. Lung cancer rate in non-screened subjects but met at the Occupational Disease Consultation Center

    Time frame: Year 7

  20. Rate of detected lung cancer and stage of detected lung cancer in the non-screened population

    Time frame: Year 3

  21. Rate of detected lung cancer and stage of detected lung cancer in the non-screened population

    Time frame: Year 5

  22. Rate of detected lung cancer and stage of detected lung cancer in the non-screened population

    Time frame: Year 7

  23. Percentage of subjects participating in all screening (over the three years)

    Time frame: Year 3

  24. Percentage of subjects participating in all screening (over the three years)

    Time frame: Year 4

  25. 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

  26. 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

  27. Validity of the detailed personalised self-administered questionnaire for the evaluation of occupational exposures

    Time frame: Day 0

  28. Number of cases recognized as occupational disease (for lung cancer or other occupational diseases)

    Time frame: Year 2

  29. Proportion of invasive diagnostic procedures

    Time frame: Day 0

  30. Proportion of invasive diagnostic procedures

    Time frame: Year 1

  31. Proportion of invasive diagnostic procedures

    Time frame: Year 2

  32. Proportion of non-invasive diagnostic procedures

    Time frame: Day 0

  33. Proportion of non-invasive diagnostic procedures

    Time frame: Year 1

  34. Proportion of non-invasive diagnostic procedures

    Time frame: Year 2

  35. Proportion of serious and non-serious adverse events related to screening

    Time frame: Day 0

  36. Proportion of serious and non-serious adverse events related to screening

    Time frame: Year 1

  37. Proportion of serious and non-serious adverse events related to screening

    Time frame: Year 2

  38. Proportion of subjects stopping smoking at each stage of screening

    Time frame: Day 0

  39. Proportion of subjects stopping smoking at each stage of screening

    Time frame: Year 1

  40. Proportion of subjects stopping smoking at each stage of screening

    Time frame: Year 2

  41. 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)

    Time frame: Day 0

  42. 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)

    Time frame: Year 1

  43. 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)

    Time frame: Year 3

  44. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Subject inclusion

  45. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Year 1

  46. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Year 2

  47. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Year 3

  48. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Year 4

  49. Number of additional radiological examinations performed besides the prescribed CT scans of the protocol

    Time frame: Year 5

  50. Number of hospitalizations

    Time frame: Subject inclusion

  51. Number of hospitalizations

    Time frame: Year 1

  52. Number of hospitalizations

    Time frame: Year 2

  53. Number of hospitalizations

    Time frame: Year 3

  54. Number of hospitalizations

    Time frame: Year 4

  55. Number of hospitalizations

    Time frame: Year 5

  56. Number of lung surgery

    Time frame: Subject inclusion

  57. Number of lung surgery

    Time frame: Year 1

  58. Number of lung surgery

    Time frame: Year 2

  59. Number of lung surgery

    Time frame: Year 3

  60. Number of lung surgery

    Time frame: Year 4

  61. Number of lung surgery

    Time frame: Year 5

  62. Number of chemotherapy

    Time frame: Day 0

  63. Number of chemotherapy

    Time frame: Year 1

  64. Number of chemotherapy

    Time frame: Year 2

  65. Number of chemotherapy

    Time frame: Year 3

  66. Number of chemotherapy

    Time frame: Year 4

  67. Number of chemotherapy

    Time frame: Year 5

07

Study locations

2 of 8 sites recruiting
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, 33076, France
    • Fleur Delva, MD · Contact · fleur.delva@chu-bordeaux.fr · 557821684
    • Patrick Brochard, Pr · Sub investigator
    • Catherine Verdun-Esquer, MD · Sub investigator
    • Fleur Delva, MD · Principal investigator
    Recruiting
  • Université de Bordeaux
    Bordeaux, 33076, France
    Active, not recruiting
  • Centre Hospitalier Universitaire de Brest
    Brest, 29609, France
    • David LUCAS, Dr · Contact
    • Jean-Dominique Dewitte, MD · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Universitaire de Caen
    Caen, 14033, France
    • Bénédicte Clin-Godart, Pr · Contact
    • Bénédicte Clin-Godart, Pr · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94010, France
    • Jean-Claude Pairon, Pr · Contact · JC.Pairon@chicreteil.fr · 157022093
    • Nadia Abdessemed, MD · Sub investigator
    • Pascal Andujar, Pr · Sub investigator
    • Mireille Matrat, MD · Sub investigator
    Recruiting
  • Centre Hospitalier Universitaire de Rennes
    Rennes, 35033, France
    • Christophe Paris, Pr · Contact
    • Christophe Paris, Pr · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Universitaire de Rouen
    Rouen, 76032, France
    • Jean-François Gehanno, Pr · Contact
    • Antoine Gislard, MD · Principal investigator
    Not yet recruiting
  • Hôpital d'Instruction des Armées Sainte-Anne
    Toulon, 83000, France
    • Olivier Bylicki, Dr · Contact
    • Olivier Bylicki, MD · Principal investigator
    Not yet recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03562052
Lead sponsor
Centre Hospitalier Intercommunal Creteil
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
First posted
Jun 19, 2018
Start date
Jul 22, 2021
Primary completion
Jul 2026 (estimated)
Completion
Jul 31, 2031 (estimated)
Last update
Jul 9, 2024

Study contacts

Jean-Claude Pairon, Pr
Contact
JC.Pairon@chicreteil.fr
157022093 ext. 0033
Jean-Claude Pairon, Pr
principal investigator · Centre Hospitalier Interconnmunal de Créteil

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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