Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT02991924
• Lead Sponsor: National Cancer Center, Korea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-14
• Primary Completion: 2019-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Molecular test	for each subject; up to 60 days, available in all subjects ; 3 years	EGFR, ALK etc
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

Trial Locations

Locations (1)

National Cancer Center (NCC) Korea; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of