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Optimizing Bronchopulmonary Cancer Screening (OPTI-DEPIST)

I

Institut Curie

Status

Enrolling

Conditions

Diagnoses Disease
Bronchopulmonary Disease

Treatments

Other: Inclusion
Other: Chest CTscan and follow-up
Other: Screening

Study type

Interventional

Funder types

Other

Identifiers

NCT06439901
IC 2023-11

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.

Full description

The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualists and its affiliated health centers, is based on a clear, simple and functional process:

  • Definition of eligibility criteria for screening, based on those of the NELSON study,
  • Referral and consultation by a health center physician trained in these criteria,
  • Referral and performance of a chest Computer Tomography Scanner (CTscan) according to the same recommendations,
  • Structured centralized reading and interpretation of CTscan images,
  • Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,
  • Referral to a tobacco unit in a health center for smokers who have not stopped smoking,
  • Organization of follow-up and continuation of the screening program.

Enrollment

500 estimated patients

Sex

All

Ages

50 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participant aged 50 to 74.

  • Resident in the Île-de-France region.

  • Active smoker or quit smoker for 10 years or less:

    1. more than 10 cigarettes a day for more than 30 years,
    2. more than 15 cigarettes a day for more than 25 years.
  • The participant has been informed and has signed the consent form.

  • Social Security System affiliation.

  • Willingness to participate in a smoking cessation program, if currently smoking.

Exclusion criteria

  • Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix).
  • Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening.
  • Weight >= 140 kg.
  • Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations.
  • Inability to climb two flights of stairs without stopping.
  • A thoracic CTscan performed within the previous year.
  • Persons deprived of liberty or under guardianship.
  • Impossibility to undergo the medical monitoring of the trial for geographical, social or psychological reasons.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Screening for primary prevention of bronchopulmonary cancer
Other group
Description:
Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),
Treatment:
Other: Screening
Other: Chest CTscan and follow-up
Other: Inclusion

Trial contacts and locations

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Central trial contact

Nicolas GiRARD, PhD; Catherine DANIEL, MD

Data sourced from clinicaltrials.gov

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