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| Name | Class |
|---|---|
| Institut Mutualiste Montsouris | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening for primary prevention of bronchopulmonary cancer | Other | Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening | Other | A first step to identify and recruit people eligible for screening, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of first CTscan for bronchopulmonary cancer screening | 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). | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate among people registering on the web platform | 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. | 36 months |
| Rate of completion of the inclusion visit among people registered on the web platform, |
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Inclusion Criteria:
Participant aged 50 to 74.
Resident in the Île-de-France region.
Active smoker or quit smoker for 10 years or less:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine DANIEL, MD | Contact | +33 1 44 32 40 00 | catherine.daniel@curie.fr | |
| Nicolas GiRARD, PhD | Contact | +33 1 44 32 40 00 | nicolas.girard@curie.fr |
| Name | Affiliation | Role |
|---|---|---|
| Catherine DANIEL, MD | Institut Curie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre CTPS Bobigny Bondy | Not yet recruiting | Bobigny | 93000 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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Multicentre, Interregional , feasibility study
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| Inclusion | Other | A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center, |
|
| Chest CTscan and follow-up | Other | A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care. |
|
Ratio of the number of people who have completed the inclusion visit to the total number of eligible people registered on the web platform |
| 36 months |
| Rate of completion of screening scanners at 1 year according to NELSON trial schedule | Ratio of the number of people who had their 1-year screening CTscan among those eligible for a 1-year CTscan | 48 months |
| Rate of completion of screening scanners at 3 years according to NELSON trial schedule | Ratio of the number of people who had their 3-year screening CTscan among those eligible for a 3-year CTscan | 72 months |
| Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule | Ratio of the number of people who had their 5.5-year screening CTscan among those eligible for a 5.5-year CTscan | 102 months |
| Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan | 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. | 102 months |
| Rate of complications related to complementary explorations | Ratio between the number of people with complications related to complementary explorations and the population having undergone a CT scan. | 102 months |
| Smoking cessation rates during the screening program | 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. | 102 months |
| Rate of early-stage bronchopulmonary cancers identified | 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 | 102 months |
| Rate of positive screening without bronchopulmonary cancer | 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 | 102 months |
| Centre Municipal de Santé Simone Veil | Recruiting | Issy-les-Moulineaux | 92160 | France |
|
| Centre Municipal de Santé Jacqueline Akoun-Cornet | Not yet recruiting | Malakoff | 92240 | France |
|
| Centre Municipal de Santé Maurice Ténine | Recruiting | Malakoff | 92240 | France |
|
| Centre de Santé Square de la Mutualité | Recruiting | Paris | 75005 | France |
|
| Institut Curie | Not yet recruiting | Paris | 75248 | France |
|
| Institut Mutualiste Montsouris | Not yet recruiting | Paris | 75674 | France |
|
| Centre de Santé MGEN | Recruiting | Paris | 75738 | France |
|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |