LUMASCAN-2: Experimentation With Screening for Bronchopulmonary Cancer and Primary Cardiovascular Prevention, Early Management of COPD and an Offer Exempted From Smoking Cessation

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05440123
Collaborator
(none)
300
108

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: screening for bronchopulmonary cancer

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Bronchopulmonary Cancer Screening Program and Primary Cardiovascular Prevention, Early Management of COPD and Smoking Cessation
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2031

Arms and Interventions

Arm 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.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Rate of population participation in PBC screening [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 74 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT05440123
Other Study ID Numbers:
  • LUMASCAN-2
First Posted:
Jun 30, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jun 30, 2022