Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer

April 3, 2024 updated by: Bin Hwangbo, National Cancer Center, Korea

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center (NCC) Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Non-small cell lung cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
When confirmative diagnosis are available in all subjects ;3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic values of endoscopic staging
Time Frame: When confirmative diagnosis are available in all subjects ;3 years
sensitivity, negative predictive value, accuracy
When confirmative diagnosis are available in all subjects ;3 years
Survival
Time Frame: After the diagnosis ; 7 years
survival after lung cancer treatment
After the diagnosis ; 7 years
Molecular test
Time Frame: for each subject; up to 60 days, available in all subjects ; 3 years
EGFR, ALK etc
for each subject; up to 60 days, available in all subjects ; 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Bin Hwangbo, PhD, National Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimated)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2016-0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe