Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02991924

Collaborator

Seoul National University Hospital (Other), Samsung Medical Center (Other), Asan Medical Center (Other), Seoul National University Bundang Hospital (Other)

600

Enrollment

Location

120

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jul 1, 2026

Outcome Measures

Primary Outcome Measures

Relative risk of risk factors for mediastinal metastasis [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 Outcome Measures

Diagnostic values of endoscopic staging [When confirmative diagnosis are available in all subjects ;3 years]
sensitivity, negative predictive value, accuracy
Survival [After the diagnosis ; 7 years]
survival after lung cancer treatment
Molecular test [for each subject; up to 60 days, available in all subjects ; 3 years]
EGFR, ALK etc

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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