Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02991924
• Other study ID #: NCC2016-0156
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: July 2026
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center (NCC) Korea	Goyang	Gyeonggi-do

Sponsors (5)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Asan Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative risk of risk factors for mediastinal metastasis	risk factors; CT staging (N0-3), PET staging (N0-3), tumor location(central or peripheral), tumor size and histologic types of lung cancer.	When confirmative diagnosis are available in all subjects ;3 years
Secondary	Diagnostic values of endoscopic staging	sensitivity, negative predictive value, accuracy	When confirmative diagnosis are available in all subjects ;3 years
Secondary	Survival	survival after lung cancer treatment	After the diagnosis ; 7 years
Secondary	Molecular test	EGFR, ALK etc	for each subject; up to 60 days, available in all subjects ; 3 years