Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer

Study Overview
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Brief Summary
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This is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. The main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.

Detailed Description
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Surgical resection remains the best chance for cure in patients with early-stage non-small-cell lung cancer (NSCLC). Unfortunately, approximately 30-50% of patients will relapse within 5-year of curative surgery despite early TNM-stage. The Identification of prognostic biomarkers of relapse is a necessity. Among them, extracellular vesicles (exosomes) study seems promising in early stage cancers and samples directly in tumor-draining vein to. The pulmonary vein is draining blood directly from the lungs and sampling at this location could provide a higher yield for oncosome. The litterature reports that Navarro et al. are the only team to have link exosome characteristics to oncological outcomes following surgery. The investigators propose to analyze the molecular profiling mediated by these extracellular vesicles in the tumor-draining vein of operated patients. A peripheral blood sample is recolted before surgery (D-1 or D0). During oncological lung surgery, the pulmonary tumor-drainage vein is first exposed and punctured with a needle prior to subsequent surgical manipulation for resection (D0). A piece of resected tumor will be analyzed for the study (D0). Quantification and size distribution of exosome and molecular cargo of exosome in blood samples (peripheral and pulmonary vein) and tumor are analyzed (DNA sequencing). Standard clinical and radiological follow-up is then performed and 2-year overall survival and 2-year disease free-survival are checked.

Official Title
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Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce

Conditions
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Lung Cancer, Exosomes, Non Small Cell Lung Cancer

Intervention / Treatment
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* Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan Exclusion Criteria: Pure ground glass nodule, Neoadjuvant therapy, Second cancer or cancer in the 5 years, Pregnancy, Patients <18 years-old, Tutorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood samples at 2 sites: peripheral vein and tumor-draining vein<br>D0: surgery (inclusion): oncological lung resection Blood samples at 2 sites: peripheral vein and tumor-draining vein Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call) | Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein<br>* D0: surgery (inclusion): oncological lung resection Blood samples at 2 sites: peripheral vein and tumor-draining vein Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion | Concentration of extracellular vesicule (million of particule/mL of blood) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size distribution, molecular profiling of peripheral vein exosome sat inclusion | The size distribution of extracellular vesicules harvested | 36 months | 
| Mutations and polymorphism in resected lung cancer | Analyze of the molecular profile in the resected tumor tissus | 36 months | 
| Overall survival | overall survival | 36 months | 
| Two-year disease-free survival | Two-year disease-free survival | 24 months |