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

NCT ID: NCT05440123

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2032-11-30

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

Conditions

the Rate of Participation in Screening for PBC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

screening for bronchopulmonary cancer

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sébastien Gendarme, MD

Role: CONTACT

sebastien.gendarme@chicreteil.fr

01.57.02.20.90

Camille JUNG

Role: CONTACT

camille.jung@chicreteil.fr

0145175000

Other Identifiers

LUMASCAN-2

Identifier Type: -

Identifier Source: org_study_id