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

Lung Cancer Clinical Trial

— ExOnSite-Pro  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04939324
• Other study ID #: 87RI20-0067 (ExOnSite-Pro)
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: June 6, 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 6, 2024
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exosomes
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Size distribution, molecular profiling of peripheral vein exosome sat inclusion	The size distribution of extracellular vesicules harvested	36 months
Secondary	Mutations and polymorphism in resected lung cancer	Analyze of the molecular profile in the resected tumor tissus	36 months
Secondary	Overall survival	overall survival	36 months
Secondary	Two-year disease-free survival	Two-year disease-free survival	24 months