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NCT Number: NCT04939324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Primary outcomes

  1. Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion

    Time frame: 36 months

    Concentration of extracellular vesicule (million of particule/mL of blood)

Secondary outcomes

  1. Size distribution, molecular profiling of peripheral vein exosome sat inclusion

    Time frame: 36 months

    The size distribution of extracellular vesicules harvested

  2. Mutations and polymorphism in resected lung cancer

    Time frame: 36 months

    Analyze of the molecular profile in the resected tumor tissus

  3. Overall survival

    Time frame: 36 months

    overall survival

  4. Two-year disease-free survival

    Time frame: 24 months

    Two-year disease-free survival

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: ExOnSite-Pro

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jun 25, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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