Actively Recruiting

Age: 55Years - 74Years
All Genders
Healthy Volunteers
NCT03562052

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2024-07-09

6000

Participants Needed

8

Research Sites

523 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Intercommunal Creteil

Lead Sponsor

U

University Hospital, Bordeaux

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

Who Can Participate

Age: 55Years - 74Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Current or former smokers aged 55 to 74 years
  • Smoking history of 30 pack-years or more
  • If former smoker, quit less than 15 years ago
  • Current or past occupational exposure to lung carcinogens according to a specific exposure algorithm
Not Eligible

You will not qualify if you...

  • Presence of clinical signs of lung cancer
  • History of lung cancer
  • Serious short-term life-threatening health conditions
  • No occupational exposure to lung carcinogens by study criteria
  • Already enrolled in another prospective cohort study
  • Chest CT scan performed within the previous year
  • No tobacco exposure or insufficient tobacco exposure or quit smoking more than 15 years ago

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Trial Site Locations

Total: 8 locations

1

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France, 33076

Actively Recruiting

2

Université de Bordeaux

Bordeaux, France, 33076

Active, Not Recruiting

3

Centre Hospitalier Universitaire de Brest

Brest, France, 29609

Not Yet Recruiting

4

Centre Hospitalier Universitaire de Caen

Caen, France, 14033

Not Yet Recruiting

5

Centre Hospitalier Intercommunal de Créteil

Créteil, France, 94010

Actively Recruiting

6

Centre Hospitalier Universitaire de Rennes

Rennes, France, 35033

Not Yet Recruiting

7

Centre Hospitalier Universitaire de Rouen

Rouen, France, 76032

Not Yet Recruiting

8

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, France, 83000

Not Yet Recruiting

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Research Team

J

Jean-Claude Pairon, Pr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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