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Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

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ClinicalTrials.gov Identifier: NCT02991924
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Information provided by (Responsible Party):

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
Non Small Cell Lung Cancer

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Relative risk of risk factors for mediastinal metastasis [ Time Frame: 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 :
  1. Diagnostic values of endoscopic staging [ Time Frame: When confirmative diagnosis are available in all subjects ;3 years ]
    sensitivity, negative predictive value, accuracy

  2. Survival [ Time Frame: After the diagnosis ; 7 years ]
    survival after lung cancer treatment

  3. Molecular test [ Time Frame: for each subject; up to 60 days, available in all subjects ; 3 years ]
    EGFR, ALK etc

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-small cell lung cancer

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991924

Contact: Hye sook Lee, CRC 82-31-9201117 hbb@ncc.re.kr
Contact: Ju- Jae Kim, MD 82-31-9201115 joohaekim@ncc.re.kr

Korea, Republic of
National Cancer Center (NCC) Korea Recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Soonmi Kim, NR    +82-31-920-0425    irb@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Seoul National University Bundang Hospital
Principal Investigator: Bin Hwangbo, PhD National Cancer Center
More Information

Responsible Party: Bin Hwangbo, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02991924     History of Changes
Other Study ID Numbers: NCC2016-0156
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bin Hwangbo, National Cancer Center, Korea:
endobronchial ultrasound
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms