Exosomes, Lung Cancer, Non Small Cell Lung Cancer
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALBlood 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)
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion | 36 months | Concentration of extracellular vesicule (million of particule/mL of blood) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size distribution, molecular profiling of peripheral vein exosome sat inclusion | 36 months | The size distribution of extracellular vesicules harvested |
| Mutations and polymorphism in resected lung cancer | 36 months | Analyze of the molecular profile in the resected tumor tissus |
| Overall survival | 36 months | overall survival |
| Two-year disease-free survival | 24 months | Two-year disease-free survival |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJérémy Tricard, MD
University Hospital, Limoges
Outcome results
None listed