Validation of biomarkers for lung cancer risk in patients with cardiovascular disease
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
This study is testing if certain biological markers can help identify lung cancer risk in patients with heart disease who smoke or used to smoke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06387017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include active or former smokers aged 45-75 with a history of smoking-related atheromatous disease or those at risk of lung cancer due to other tobacco-related conditions.
Not a fit: Patients who are not smokers or former smokers, or those without any smoking-related atheromatous disease or risk factors for lung cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of lung cancer in high-risk patients, allowing for timely and potentially curative interventions.
How similar studies have performed: Other studies have shown promise in using biomarkers for lung cancer detection, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Marseille
- Assistance Publique Hopitaux de Marseille — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Amandine ROLLAND-BRUN
- Email: amandine.rolland@ap-hm.fr
- Phone: 491381245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.