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NCT03562052Recruiting

Lung Cancer Screening in a Population Exposed to Occupational Lung Carcinogens

LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens

Source: ClinicalTrials.gov · Last updated 9 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
6000 (estimated)
First submitted
16 Apr 2018
Start date
22 Jul 2021
Primary completion date
Jul 2026
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Diseases
Lung cancer
NCT number
NCT03562052

What you commit to

  • Study type: Observational
  • Planned participants: 6000
  • From 22 Jul 2021 to the primary completion date, Jul 2026
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects already assessed by chest CT scan during the previous year

Other illness

  • Presence of clinical signs of lung cancer
  • Subjects with a history of lung cancer

Other

  • 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
  • No tobacco exposure or insufficient tobacco exposure or smoking cessation for more than 15 years.

Who the study is looking for

  • 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)

Age in the registry: 55 years to 74 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Université de Bordeaux
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BordeauxFranceActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire de Brest
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BrestFranceNot yet recruiting
Centre Hospitalier Universitaire de Caen
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CaenFranceNot yet recruiting
Centre Hospitalier Intercommunal de Créteil
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CréteilFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceNot yet recruiting
Centre Hospitalier Universitaire de Rouen
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RouenFranceNot yet recruiting
Hopital d instruction des armees sainte anne
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ToulonFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.