Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation

Not yet recruiting

• Conditions: the Rate of Participation in Screening for PBC
• Interventions: Other: screening for bronchopulmonary cancer

• Registration Number: NCT05440123
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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.

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Study Start: 2023-11-01
• Primary Completion: 2027-11
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bronchopulmonary cancer	screening for 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.

Primary Outcome Measures

Name	Time	Method
Rate of population participation in PBC screening	Baseline