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

NCT ID: NCT04939324

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2024-06-06

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.

Conditions

Lung Cancer; Exosomes; Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

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

Intervention Type: BIOLOGICAL

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)

Interventions

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)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérémy Tricard, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

CHU de Limoges

Limoges, , France

Countries

France

Other Identifiers

87RI20-0067 (ExOnSite-Pro)

Identifier Type: -

Identifier Source: org_study_id