Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer (ExOnSite-Pro)

University of Limoges (UL)

Status: Active, not recruiting

Conditions: Lung Cancer; Non Small Cell Lung Cancer; Exosomes

Treatments: Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein

Study type: Interventional

Funder types: Other

Identifiers

NCT04939324

87RI20-0067 (ExOnSite-Pro)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Blood samples at 2 sites: peripheral vein and tumor-draining vein

Other group

Description:

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)

Treatment:

Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein