Clinical trial · Interventional
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
NCT06387017CI-TRIAL-00076531BIOCEPTIONrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atheroma | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-progressive Cancer > 5 Years | — | UNRESOLVED | — |
| Smoking-related Pathology | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling | Diagnostic Test | — | UNRESOLVED |
| low dose CT scan | Radiation | — | UNRESOLVED |
| stool collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- all patients
- interventionNames
- Diagnostic Test: blood sampling
- Diagnostic Test: stool collection
- Radiation: low dose CT scan
Primary outcomes (1)
- measure
- biomarker group validation
- timeFrame
- 51 months
- description
- Sensitivity and specificity of each biomarker
Secondary outcomes (8)
- measure
- Describe changes in biomarkers over time
- timeFrame
- 51 months
- description
- reporting the value of each biomarker at each patient's visit to visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 womenReferences
Publications (0)
Data not yet available
No reference posted for this study.