Optimizing Bronchopulmonary Cancer Screening

Not Applicable

Recruiting

• Conditions: Diagnoses Disease; Bronchopulmonary Disease
• Interventions: Other: Screening; Other: Inclusion; Other: Chest CTscan and follow-up

• Registration Number: NCT06439901
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Status Verified: 2025-01
• Study Start: 2025-01-17
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2032-01-17
• Study Completion: 2033-01-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of first CTscan for bronchopulmonary cancer screening	36 months	Rate of completion of a first bronchopulmonary cancer screening among people who have joined the program (i.e. registered on the program's web platform and met the inclusion criteria).

Secondary Outcome Measures

Name	Time	Method
Rate of completion of screening scanners at 3 years according to NELSON trial schedule	72 months	Ratio of the number of people who had their 3-year screening CTscan among those eligible for a 3-year CTscan
Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan	102 months	Demographic characteristics at inclusion will be compared between people who have or have not had at least one nodule detected on one of the 4 CTscan.
Smoking cessation rates during the screening program	102 months	The rate of newly non-smoking subjects will be calculated for each type of approach by dividing the number of newly non-smoking subjects by the number of subjects people included in the study.
Rate of positive screening without bronchopulmonary cancer	102 months	The rate of false-positive screening will be calculated by people who have at least one positive screening scanner, but whose histology has not confirmed their malignancy, to the number people who had a scanner
Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule	102 months	Ratio of the number of people who had their 5.5-year screening CTscan among those eligible for a 5.5-year CTscan
Rate of early-stage bronchopulmonary cancers identified	102 months	Number of bronchopulmonary cancers detected at an early stage (stage I or stage II) to the total number of people who underwent a CTscan at inclusion
Eligibility rate among people registering on the web platform	36 months	Ratio of the number of eligible people (meeting all inclusion and inclusion criteria and no non-inclusion criteria) to the total number of people registered on the web platform.
Rate of completion of screening scanners at 1 year according to NELSON trial schedule	48 months	Ratio of the number of people who had their 1-year screening CTscan among those eligible for a 1-year CTscan
Rate of completion of the inclusion visit among people registered on the web platform,	36 months	Ratio of the number of people who have completed the inclusion visit to the total number of eligible people registered on the web platform
Rate of complications related to complementary explorations	102 months	Ratio between the number of people with complications related to complementary explorations and the population having undergone a CT scan.

Trial Locations

Locations (8)

Centre CTPS Bobigny Bondy; 🇫🇷 Bobigny, France

Centre Municipal de Santé Simone Veil; 🇫🇷 Issy-les-Moulineaux, France

Centre Municipal de Santé Jacqueline Akoun-Cornet; 🇫🇷 Malakoff, France

Centre Municipal de Santé Maurice Ténine; 🇫🇷 Malakoff, France

Centre de Santé Square de la Mutualité; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Centre de Santé MGEN; 🇫🇷 Paris, France