Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT06387017

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

Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-04-26

750

Participants Needed

1

Research Sites

273 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants of PREVALUNG or PREVALUNG ETOILE studies
  • Active or former smokers who smoked daily for at least 10 years
  • Age between 45 and 75 years
  • Medical follow-up for smoking-related atheromatous disease or moderate/high coronary calcium score
  • Individuals at risk of lung cancer without atheromatous disease but with tobacco-related diseases (chronic bronchitis or non-progressive cancer > 5 years) or meeting NLST, NELSON, or American lung cancer screening criteria
  • Smoking history meeting NLST: 55-74 years old with at least 30 pack-years, active or quit less than 15 years ago
  • Smoking history meeting NELSON: 50-75 years old, smoking >15 cigarettes/day for >25 years or >10 cigarettes/day for >30 years, active or quit less than 10 years ago
  • Smoking history meeting American recommendations: 50-80 years old with 20 or more pack-years
Not Eligible

You will not qualify if you...

  • Cancer diagnosed less than 5 years ago except certain in situ or non-invasive cancers
  • Symptoms of lung cancer such as involuntary weight loss over 7 kg in 1 year or coughing up blood
  • Known pulmonary nodule needing specialized follow-up
  • History of pulmonary fibrosis or pulmonary hypertension
  • Active lung infection
  • Severe heart or lung failure causing resting breathlessness
  • Performance status of 2, 3, or 4 (WHO scale)
  • Not affiliated with social security system
  • Deprived of liberty or under guardianship/trusteeship
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Assistance Publique Hopitaux de Marseille

Marseille, France

Actively Recruiting

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Research Team

A

Amandine ROLLAND-BRUN

CONTACT

D

David BOULATE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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