Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens (LUCSO)

• ClinicalTrials.gov Identifier: NCT03562052
• Recruitment Status: Not yet recruiting
• First Posted: June 19, 2018
• Last Update Posted: June 4, 2021
• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: University Hospital, Bordeaux; Rennes University Hospital; Centre Hospitalier Régional et Universitaire de Brest; University Hospital, Caen; Centre Hospitalier Universitaire de Rouen; Direction Centrale du Service de Santé des Armées
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal Creteil

Study Description

Brief 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.

Condition or disease
Lung Cancer

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 6000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens
• Estimated Study Start Date: August 2021
• Estimated Primary Completion Date: July 2026
• Estimated Study Completion Date: July 31, 2031

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Rate of detected lung cancer [ Time Frame: Year 2 ]
   The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
2. Rate of detected lung cancer [ Time Frame: Day 0 ]
   The proportion of subjects with lung cancer detected among the subjects performing the low-dose chest CT scan
3. Participation rate [ Time Frame: Day 0 ]
   The proportion of subjects performing the low-dose chest CT scan among eligible responders during the first phase of the study
4. Rate of detected lung cancer in subjects exposed to occupational carcinogens [ Time Frame: Day 0 ]
   The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
5. Rate of detected lung cancer in subjects exposed to occupational carcinogens [ Time Frame: Year 1 ]
   The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
6. Rate of detected lung cancer in subjects exposed to occupational carcinogens [ Time Frame: Year 2 ]
   The proportion of subjects with lung cancer detected among the subjects exposed to occupational carcinogens and performing the low-dose chest CT scan
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 [ Time Frame: Year 3 ]
    The proportion of subjects with smoking cessation among smokers
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 ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: 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.

Criteria

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:

• 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.

Contacts and Locations

Contacts

Contact: Jean-Claude Pairon, Pr; 157022093 ext 0033; JC.Pairon@chicreteil.fr

Locations

France

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France, 33076

Contact: Fleur Delva, MD 557821684 ext 0033 fleur.delva@chu-bordeaux.fr

Sub-Investigator: Patrick Brochard, Pr

Sub-Investigator: Catherine Verdun-Esquer, MD

Principal Investigator: Fleur Delva, MD

Université de Bordeaux

Bordeaux, France, 33076

Centre Hospitalier Universitaire de Brest

Brest, France, 29609

Contact: Jean-Dominique Dewitte, Pr

Principal Investigator: Jean-Dominique Dewitte, MD

Centre Hospitalier Universitaire de Caen

Caen, France, 14033

Contact: Bénédicte Clin-Godart, Pr

Principal Investigator: Bénédicte Clin-Godart, Pr

Centre Hospitalier Intercommunal de Créteil

Créteil, France, 94010

Contact: Jean-Claude Pairon, Pr 157022093 ext 0033 JC.Pairon@chicreteil.fr

Sub-Investigator: Nadia Abdessemed, MD

Sub-Investigator: Pascal Andujar, Pr

Sub-Investigator: Mireille Matrat, MD

Centre Hospitalier Universitaire de Rennes

Rennes, France, 35033

Contact: Christophe Paris, Pr

Principal Investigator: Christophe Paris, Pr

Centre Hospitalier Universitaire de Rouen

Rouen, France, 76032

Contact: Jean-François Gehanno, Pr

Principal Investigator: Antoine Gislard, MD

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, France, 83000

Contact: Olivier Bylicki, Dr

Principal Investigator: Olivier Bylicki, MD

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

University Hospital, Bordeaux

Rennes University Hospital

Centre Hospitalier Régional et Universitaire de Brest

University Hospital, Caen

Centre Hospitalier Universitaire de Rouen

Direction Centrale du Service de Santé des Armées

Investigators

• Principal Investigator: Jean-Claude Pairon, Pr; Centre Hospitalier Interconnmunal de Créteil

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaïd C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pélissier 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.

• Responsible Party: Centre Hospitalier Intercommunal Creteil
• ClinicalTrials.gov Identifier: NCT03562052
• Other Study ID Numbers: LUCSO
• First Posted: June 19, 2018
• Last Update Posted: June 4, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Intercommunal Creteil:

Cancer; Lung; Occupational carcinogens; Tobacco smoking; Screening; Chest CT Scan; Asbestos

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases