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NCT06387017Recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
750 (estimated)
First submitted
4 Apr 2024
Start date
2 Apr 2024
Primary completion date
31 Jul 2028
Lead sponsor
Assistance Publique Hopitaux De Marseille
Diseases
Lung cancer
NCT number
NCT06387017

What you commit to

  • Study type: Interventional
  • Planned participants: 750
  • From 2 Apr 2024 to the primary completion date, 31 Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • symptoms of lung cancer (involuntary weight loss \> 7 kg in 1 year, hemoptysis)
  • known history of pulmonary nodule requiring specialized follow-up
  • history of pulmonary fibrosis or pulmonary hypertension
  • active pulmonary parenchymal infection
  • severe cardiac or respiratory insufficiency (rest dyspnea)

Age

  • cancer history \< 5 years (except carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin, non-invasive urothelial carcinoma treated for curative purposes without CT lung surveillance, prostate cancer with unmeasurable PSA)

Other

  • performance status (WHO) 2, 3 or 4
  • patient not affiliated to the social security system (beneficiary or beneficiary's beneficiary)
  • patient deprived of liberty
  • patients under guardianship or trusteeship
  • pregnant or breast-feeding women

Who the study is looking for

  • 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

Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.