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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Exosomes
• Intervention / Treatment: Biological: Blood samples at 2 sites: peripheral vein and tumor-draining vein

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Jérémy Tricard, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Anticipated): August 21, 2023
• Study Completion (Anticipated): June 6, 2024

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 87RI20-0067 (ExOnSite-Pro)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No