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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04939324
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2021-05-31
• Study Start: 2021-06-21
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10
• Primary Completion: 2023-08-21
• Study Completion: 2024-06-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Limoges; 🇫🇷 Limoges, France