Clinical trial NCT06439901: Optimizing Bronchopulmonary Cancer Screening
Official title: Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchopulmonary Disease
Diagnoses Disease
Keywords: bronchopulmonary cancer
screening
primary prevention
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: Institut Mutualiste Montsouris
First posted: 2024-06-03
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentre, Interregional , feasibility study
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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:

  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.

Primary outcomes:
measure: Rate of first CTscan for bronchopulmonary cancer screening
timeFrame: 36 months
Secondary outcomes:
measure: Eligibility rate among people registering on the web platform
timeFrame: 36 months
measure: Rate of completion of the inclusion visit among people registered on the web platform,
timeFrame: 36 months
measure: Rate of completion of screening scanners at 1 year according to NELSON trial schedule
timeFrame: 48 months
measure: Rate of completion of screening scanners at 3 years according to NELSON trial schedule
timeFrame: 72 months
measure: Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule
timeFrame: 102 months
measure: Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan
timeFrame: 102 months
measure: Rate of complications related to complementary explorations
timeFrame: 102 months
measure: Smoking cessation rates during the screening program
timeFrame: 102 months
measure: Rate of early-stage bronchopulmonary cancers identified
timeFrame: 102 months
measure: Rate of positive screening without bronchopulmonary cancer
timeFrame: 102 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre CTPS Bobigny Bondy
city: Issy-les-Moulineaux
country: France
facility: Centre Municipal de Santé Simone Veil
city: Malakoff
country: France
facility: Centre Municipal de Santé Jacqueline Akoun-Cornet
city: Malakoff
country: France
facility: Centre Municipal de Santé Maurice Ténine
city: Paris
country: France
facility: Centre de Santé Square de la Mutualité
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Centre de Santé MGEN
Study officials:
affiliation: Institut Curie
name: Catherine DANIEL, MD
role: STUDY_DIRECTOR
References: