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Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

Primary Purpose

Non Small Cell Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EBUS-TBNA, integrated PET/CT
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven non-small cell lung cancer
  • Patients who have initially histologically proven N2 disease (Stage IIIA)
  • Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
  • Written informed consent

Exclusion Criteria:

  • Contraindications for bronchoscopy
  • Medically inoperable patients
  • Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment

Sites / Locations

  • NCCKorea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBUS-TBNA

Arm Description

Outcomes

Primary Outcome Measures

The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.

Secondary Outcome Measures

The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy

Full Information

First Posted
March 10, 2009
Last Updated
March 29, 2018
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00859742
Brief Title
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)
Official Title
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-staging After Induction Therapy in Non-small Cell Lung Cancer. A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer. Primary objective: 1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment. Secondary objectives: To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy To determine procedure related complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA, integrated PET/CT
Intervention Description
EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.
Primary Outcome Measure Information:
Title
The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer
Time Frame
1.5 years
Title
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven non-small cell lung cancer Patients who have initially histologically proven N2 disease (Stage IIIA) Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery Written informed consent Exclusion Criteria: Contraindications for bronchoscopy Medically inoperable patients Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Hwangbo, MD. PhD
Organizational Affiliation
Goyang, Gyeonggi-do, Korea, Republic of
Official's Role
Principal Investigator
Facility Information:
Facility Name
NCCKorea
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
411-794
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

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