Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

NCT02991924 | Active Not Recruiting DMC

• 1 other identifier: NCC2016-0156
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

endobronchial ultrasound; EBUS-TBNA; lung cancer; staging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic values of endoscopic staging

  When confirmative diagnosis are available in all subjects ;3 years

• Survival

  After the diagnosis ; 7 years

• Molecular test

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-small cell lung cancer

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

National Cancer Center (NCC) Korea

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

Location

Related Publications (1)

• Chung HS, Yoon HI, Hwangbo B, Park EY, Choi CM, Park YS, Lee K, Ji W, Park S, Lee GK, Kim TS, Kim HY, Kim MS, Lee JM. Prediction Models for Mediastinal Metastasis and Its Detection by Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in Potentially Operable Non-Small Cell Lung Cancer: A Prospective Study. Chest. 2023 Sep;164(3):770-784. doi: 10.1016/j.chest.2023.03.041. Epub 2023 Apr 3.

  PMID: 37019355 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bin Hwangbo, PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 14, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)