Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation (LUMASCAN-2)
Bronchopulmonary Cancer Screening Program and Primary Cardiovascular Prevention, Early Management of COPD and Smoking Cessation
The study consists of recruiting a target population by sending a letter from the Regional Center for Cancer Screening in Ile de France.
In the screening program, a battery of examinations will be carried out at inclusion, one year, 2 years, 3 years, 4 years and 5 years.
Study Overview
Status
Intervention / Treatment
Detailed Description
The patients will be recruited by correspondence by by sending a letter from the Regional Center for Cancer Screening in Ile de France.
When the patient has agreed to participate, a screening program will be carried out The screening program includes performing a low-dose chest CT scan (STBD), spirometry, blood sampling (biobank + screening for cardiovascular risk factors) on inclusion, at 1 year and at 2 years. Subsequently, a telephone interview will be scheduled for 3 years to collect medical information, for a total follow-up period of 5 years. At each visit, a structured offer of smoking cessation will be proposed and a collection of the quality of life will be carried out. Each year, a telephone call from participants will be scheduled in order to maximize participation
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sébastien Gendarme, MD
- Phone Number: 01.57.02.20.90
- Email: sebastien.gendarme@chicreteil.fr
Study Contact Backup
- Name: Camille JUNG
- Phone Number: 0145175000
- Email: camille.jung@chicreteil.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women and men
- Age: 55 to 74 years old
- Smokers at more than 20 pack-years weaned for less than 15 years
- Affiliated to a social security organization
Exclusion Criteria:
- Presence of signs of PBC
- Subjects with a personal history of PBC of less than 5 years or under treatment
- Presence of serious comorbidities involving the vital prognosis at 6 months
- Subjects who have already benefited from a chest CT scan less than one year old.
- Refusal to participate in the study
- Absence of exposure to tobacco or insufficient exposure to tobacco or withdrawal > 15 years
- Patient on long-term oxygen therapy
- Metal implants (thorax, spine) which can cause a deterioration in the quality of the image of the low dose scanner
- Subject included in another study protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
bronchopulmonary cancer
The screening program includes performing a low-dose chest CT scan (STBD), spirometry, blood sampling (biobank + screening for cardiovascular risk factors) on inclusion, at 1 year and at 2 years. Subsequently, a telephone interview will be scheduled for 3 years to collect medical information, for a total follow-up period of 5 years. At each visit, a structured offer of smoking cessation will be proposed and a collection of the quality of life will be carried out. Each year, a telephone call from participants will be scheduled in order to maximize participation. For subjects presenting with anomalies suggestive of PBC on the STBD, a consultation in pneumo-oncology will be planned with management corresponding to routine care. |
The screening program includes performing a low-dose chest CT scan (STBD), spirometry, blood sampling (biobank + screening for cardiovascular risk factors) on inclusion, at 1 year and at 2 years.
Subsequently, a telephone interview will be scheduled for 3 years to collect medical information, for a total follow-up period of 5 years.
At each visit, a structured offer of smoking cessation will be proposed and a collection of the quality of life will be carried out.
Each year, a telephone call from participants will be scheduled in order to maximize participation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of population participation in PBC screening
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LUMASCAN-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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