Trial Title:
Optimizing Bronchopulmonary Cancer Screening
NCT ID:
NCT06439901
Condition:
Bronchopulmonary Disease
Diagnoses Disease
Conditions: Keywords:
bronchopulmonary cancer
screening
primary prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Multicentre, Interregional , feasibility study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Screening
Description:
A first step to identify and recruit people eligible for screening,
Arm group label:
Screening for primary prevention of bronchopulmonary cancer
Intervention type:
Other
Intervention name:
Inclusion
Description:
A second step for inclusion of participants, with an online self-questionnaire and
information, and an inclusion visit to the health center,
Arm group label:
Screening for primary prevention of bronchopulmonary cancer
Intervention type:
Other
Intervention name:
Chest CTscan and follow-up
Description:
A third step with an initial CTscan, with dual interpretation and appropriate management
of participants, including follow-up care.
Arm group label:
Screening for primary prevention of bronchopulmonary cancer
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.
Criteria for 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.
Gender:
All
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre CTPS Bobigny Bondy
Address:
City:
Bobigny
Zip:
93000
Country:
France
Contact:
Last name:
Hortense FONKOUA, MD
Facility:
Name:
Centre Municipal de Santé Simone Veil
Address:
City:
Issy-les-Moulineaux
Zip:
92160
Country:
France
Contact:
Last name:
Coline CORTICCHIATO, MD
Facility:
Name:
Centre Municipal de Santé Jacqueline Akoun-Cornet
Address:
City:
Malakoff
Zip:
92240
Country:
France
Contact:
Last name:
Amandine HUYGHE, MD
Facility:
Name:
Centre Municipal de Santé Maurice Ténine
Address:
City:
Malakoff
Zip:
92240
Country:
France
Contact:
Last name:
Eric MAY, MD
Facility:
Name:
Centre de Santé Square de la Mutualité
Address:
City:
Paris
Zip:
75005
Country:
France
Contact:
Last name:
Angélique SENTILHES, MD
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75248
Country:
France
Contact:
Last name:
Catherine DANIEL, MD
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Zip:
75674
Country:
France
Contact:
Last name:
Thibault VIEIRA, MD
Facility:
Name:
Centre de Santé MGEN
Address:
City:
Paris
Zip:
75738
Country:
France
Contact:
Last name:
David BLONDEEL, MD
Start date:
December 30, 2024
Completion date:
December 30, 2032
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Collaborator:
Agency:
Institut Mutualiste Montsouris
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06439901
