Non Small Cell Lung CancerNCT00859742
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)
A study testing EBUS-TBNA, integrated PET/CT in people with Non Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- EBUS-TBNA, integrated PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications for bronchoscopy
- Medically inoperable patients
- Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- EBUS-TBNA, integrated PET/CT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNA, integrated PET/CTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Experimental | Not described Receives: Procedure: EBUS-TBNA, integrated PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
Measured: 1.5 years
Secondary outcomes (2)
The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer
Measured: 1.5 years
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bin Hwangbo, National Cancer Center, Korea
- Investigators
- Bin Hwangbo, MD. PhD, Principal investigator, Goyang, Gyeonggi-do, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859742
- Sponsor's protocol ID
- NCCTS-06-211
- Status last verified
- Mar 2018
- First submitted
- 10 Mar 2009
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00859742
- Acronym / sponsor ID
- NCCTS-06-211
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Experimental | Procedure: EBUS-TBNA, integrated PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications for bronchoscopy
- Medically inoperable patients
- Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS-TBNA, integrated PET/CTEBUS-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. | Procedure or surgery | EBUS-TBNA |
Primary outcome
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
2 secondary outcomes
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
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
Time frame: 1.5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Hwangbo, MD. PhD principal investigator
Goyang, Gyeonggi-do, Korea, Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBNA, integrated PET/CT in people with Non Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.