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NCT Number: NCT02991924

Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center (NCC) Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
  • Potentially operable

Exclusion criteria

  • M1 disease
  • Inoperable T4 disease
  • Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT
  • Confirmed supraclavicular lymph node metastasis
  • Pancoast tumours
  • T1 ground glass opacity nodule (with solid part 1<cm)
  • Solid T1 (1<cm)N0 M0 by CT & PET/CT
  • Inoperable patients (after evaluating medical and surgical operability)
  • Patients who refused surgical treatment
  • Contraindications for bronchoscopy
  • Drug reaction to lidocaine, midazolam, fentanyl
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Relative risk of risk factors for mediastinal metastasis

    Time frame: When confirmative diagnosis are available in all subjects ;3 years

    risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.

Secondary outcomes

  1. Diagnostic values of endoscopic staging

    Time frame: When confirmative diagnosis are available in all subjects ;3 years

    sensitivity, negative predictive value, accuracy

  2. Survival

    Time frame: After the diagnosis ; 7 years

    survival after lung cancer treatment

  3. Molecular test

    Time frame: for each subject; up to 60 days, available in all subjects ; 3 years

    EGFR, ALK etc

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Registry information

Official study title

Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer

Important dates

Study start
2016
Primary completion
2019
Study completion
2026
First posted
Dec 14, 2016
Registry last updated
Apr 4, 2024

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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