Bronchopulmonary Disease, Diagnoses Disease
Conditions
Keywords
bronchopulmonary cancer, screening, primary prevention
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.
Interventions
OTHERScreening
A first step to identify and recruit people eligible for screening,
OTHERInclusion
A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,
OTHERChest CTscan and follow-up
A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.
Sponsors
Institut Curie
Institut Mutualiste Montsouris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multicentre, Interregional , feasibility study
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 |
| 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. |
| 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. |
| 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 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 |
| 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 |
Countries
France
Contacts
CONTACTCatherine DANIEL, MD
CONTACTNicolas GiRARD, PhD
STUDY_DIRECTORCatherine DANIEL, MD
Institut Curie
Outcome results
None listed