Mediastinal LymphadenopathyNCT01493739
EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy
An observational study of Mediastinal Lymphadenopathy and Lung Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mediastinal Lymphadenopathy, Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Jan 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis > 10mm
Who may be able to join
- Age > 18 years old
- mediastinal lymphadenopathy on Chest CT scan
- with a short-axis > 10mm
Who cannot join
- patients intolerant to bronchoscopy exam
- unstable vital sign (Blood pressure, heart rate, breath rate)
Trial locations and contacts
1 site in 1 country.
Chih-Hsi Kuo, MD contact
Fu-Tsai Chung, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei, Taipei, 112
Chih-Hsi Kuo, MD, chihhsikuo@gmail.com
Chih-Hsi Kuo, MD
About this study
This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.
Read the detailed description
A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.
- Conditions
- Mediastinal Lymphadenopathy, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lymphadenopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic rate
Measured: Participant will be followed within an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIH-HSI KUO, Chang Gung Memorial Hospital
- Investigators
- Chih-Hso Kuo, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493739
- Sponsor's protocol ID
- EBUSTBNA_01
- Status last verified
- Dec 2011
- First submitted
- 21 Nov 2011
- Last updated
- 16 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy
- ClinicalTrials.gov ID
- NCT01493739
- Acronym / sponsor ID
- EBUSTBNA_01
- Conditions
- Mediastinal Lymphadenopathy, Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 16 Dec 2011 (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.
This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.
Detailed description
A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymphadenopathy | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis > 10mm
Key inclusion criteria (3 listed)
- Age > 18 years old
- mediastinal lymphadenopathy on Chest CT scan
- with a short-axis > 10mm
Key exclusion criteria (2 listed)
- patients intolerant to bronchoscopy exam
- unstable vital sign (Blood pressure, heart rate, breath rate)
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
Diagnostic rate
Time frame: Participant will be followed within an average of three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2011.
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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.
Chih-Hsi Kuo, MD contact
Fu-Tsai Chung, MD contact
Chih-Hso Kuo, MD principal investigator
Chang Gung Memorial Hospital
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 Mediastinal Lymphadenopathy and Lung Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 16 Dec 2011. 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 Taiwan. 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?
Contact Chih-Hsi Kuo, MD (chihhsikuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic rate (time frame: Participant will be followed within an average of three months). 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 16 Dec 2011.