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Recruiting NCT06439901

Optimizing Bronchopulmonary Cancer Screening

No phase Interventional Bronchopulmonary Disease Diagnoses Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screening, Inclusion, Chest CTscan and follow-up.
Who it may be relevant to
Registry conditions: Bronchopulmonary Disease, Diagnoses Disease. Basic parameters: 50 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)

Overview

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.

Detailed 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.

Interventions

  • Other Screening
    A first step to identify and recruit people eligible for screening,
  • Other Inclusion
    A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,
  • Other Chest CTscan and follow-up
    A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.

Primary outcome measures

  • Rate of first CTscan for bronchopulmonary cancer screening [Time frame: 36 months]
Secondary outcome measures (10)
  • Eligibility rate among people registering on the web platform [Time frame: 36 months]
  • Rate of completion of the inclusion visit among people registered on the web platform, [Time frame: 36 months]
  • Rate of completion of screening scanners at 1 year according to NELSON trial schedule [Time frame: 48 months]
  • Rate of completion of screening scanners at 3 years according to NELSON trial schedule [Time frame: 72 months]
  • Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule [Time frame: 102 months]
  • Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan [Time frame: 102 months]
  • Rate of complications related to complementary explorations [Time frame: 102 months]
  • Smoking cessation rates during the screening program [Time frame: 102 months]
  • Rate of early-stage bronchopulmonary cancers identified [Time frame: 102 months]
  • Rate of positive screening without bronchopulmonary cancer [Time frame: 102 months]

Eligibility criteria

Inclusion criteria

  • Participant aged 50 to 74.
  • Resident in the Île-de-France region.
  • Active smoker or quit smoker for 10 years or less:
  • more than 10 cigarettes a day for more than 30 years,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 8 centers
  • Centre CTPS Bobigny Bondy — Bobigny
  • Centre Municipal de Santé Simone Veil — Issy-les-Moulineaux
  • Centre Municipal de Santé Jacqueline Akoun-Cornet — Malakoff
  • Centre Municipal de Santé Maurice Ténine — Malakoff
  • Centre de Santé Square de la Mutualité — Paris
  • Institut Curie — Paris
  • Institut Mutualiste Montsouris — Paris
  • Centre de Santé MGEN — Paris

Identifiers

NCT: NCT06439901 · IC 2023-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗