An interventional study of Blood samples at 2 sites: peripheral vein and tumor-draining vein in Lung Cancer, Exosomes and Non Small Cell Lung Cancer, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Diagnostic
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan
Exclusion Criteria:
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
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)
Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion
Concentration of extracellular vesicule (million of particule/mL of blood)
Time frame: 36 months
Size distribution, molecular profiling of peripheral vein exosome sat inclusion
The size distribution of extracellular vesicules harvested
Time frame: 36 months
Mutations and polymorphism in resected lung cancer
Analyze of the molecular profile in the resected tumor tissus
Time frame: 36 months
Overall survival
overall survival
Time frame: 36 months
Two-year disease-free survival
Two-year disease-free survival
Time frame: 24 months
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Limoges