Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02991924

Enrollment

600

Registered

2016-12-14

Start date

2016-07-31

Completion date

2026-07-31

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

endobronchial ultrasound, EBUS-TBNA, lung cancer, staging

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results