Non Small Cell Lung CancerNCT02991924
Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Jul 2026
- How long will I take part?
- 7 Years
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-small cell lung cancer
Who may be able to join
- Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- Potentially operable
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center (NCC) Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: 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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- endobronchial ultrasound, EBUS-TBNA, lung cancer, staging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: When confirmative diagnosis are available in all subjects ;3 years
Secondary outcomes (3)
Diagnostic values of endoscopic staging
sensitivity, negative predictive value, accuracy
Measured: When confirmative diagnosis are available in all subjects ;3 years
Survival
survival after lung cancer treatment
Measured: After the diagnosis ; 7 years
Molecular test
EGFR, ALK etc
Measured: for each subject; up to 60 days, available in all subjects ; 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Bin Hwangbo, National Cancer Center, Korea
- Investigators
- Bin Hwangbo, PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991924
- Sponsor's protocol ID
- NCC2016-0156
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2016
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37019355
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02991924
- Acronym / sponsor ID
- NCC2016-0156
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- endobronchial ultrasound, EBUS-TBNA, lung cancer, staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Seoul National University Bundang Hospital
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 Dec 2016 (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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-small cell lung cancer
Key inclusion criteria (2 listed)
- Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- Potentially operable
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Diagnostic values of endoscopic staging
Time frame: When confirmative diagnosis are available in all subjects ;3 years
Survival
Time frame: After the diagnosis ; 7 years
Molecular test
Time frame: for each subject; up to 60 days, available in all subjects ; 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 37019355Chung 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.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. 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?
Results are not available in the source record.
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?
Relative risk of risk factors for mediastinal metastasis (time frame: When confirmative diagnosis are available in all subjects ;3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991924, which also lists 1 linked publication.
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 4 Apr 2024.