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Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 1- All PREVALUNG or PREVALUNG ETOILE participants

• 2- Active or former smokers who have smoked daily for at least 10 years and have either atheromatous disease (coronary, lower limb, supra-aortic trunk, aortic, visceral or upper limb arteries) or a moderate or high coronary calcium score\*, \*\*.

• Age 45- 75 years and

• Medical follow-up for smoking-related atheromatous pathology and

• daily smoking for at least 10 years prior to disease (for smoking, there are no quantitative criteria or withdrawal times)

⁃ visual coronary calcium score quantified by a radiologist on a chest CT scan.

⁃ 3- Individuals at risk of lung cancer without atheromatous disease or moderate or high calcium score being managed for a tobacco-related disease (chronic bronchitis or non-progressive cancer \> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations)\*\*.

• Age 45- 75 and

• Medical follow-up for a smoking-related pathology:

• chronic obstructive pulmonary disease / emphysema, or

• history of non-progressive cancer \> 5 years, including ENT, lung, breast, cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia.

‣ and

‣ \- daily smoking for at least 10 years prior to the disease (for smoking, there are no quantitative criteria or withdrawal periods).

‣ Or

• Age 55 - 74

• Cumulative smoking ≥ 30 pack-years

• active or weaned for less than 15 years Or

‣ NELSON inclusion criteria :

• Age 50-75

• Smoking :

• \> 15 cigarettes /D for more than 25 years or

• \> 10 cigarettes /D for more than 30 years

• active smoking or cessation \< 10 years Or

‣ American recommendations :

• Age 50 - 80

• Smoking ≥20 PA

Locations
Other Locations
France
Assistance Publique Hopitaux de Marseille
RECRUITING
Marseille
Contact Information
Primary
Amandine ROLLAND-BRUN
amandine.rolland@ap-hm.fr
491381245
Backup
David BOULATE
david.boulate@ap-hm.fr
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2029-07
Participants
Target number of participants: 750
Treatments
Other: all patients
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov