Validation of biomarkers for lung cancer risk in patients with cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to validate candidate biomarkers associated with lung cancer risk among patients with atheromatous disease who are smokers or former smokers. Participants will undergo low-dose thoracic CT scans and provide blood and stool samples to analyze various biological profiles linked to inflammation, immunity, and microbiota. The study builds on previous findings from the PREVALUNG cohort, which identified biomarkers that may help in early lung cancer diagnosis. The goal is to improve screening pathways and potentially enhance early detection and treatment outcomes for lung cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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\*, \*\*.

Inclusion criteria:

* 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)\*\*.

Inclusion criteria :

* 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

Inclusion criteria in NLST :

* 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

Exclusion Criteria:

* 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)
* 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)
* 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

Where it's running

• Assistance Publique Hopitaux de Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: David BOULATE, Pr
• Email: david.boulate@ap-hm.fr
• Phone: +33491966018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.