Lung DiseaseNCT02168036
Study of Biologic Materials From the Mediastinal Lymph Nodes From Patients With Lung Disease.
An observational study of Lung Disease and Inflammation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this protocol is to obtain biologic materials from the mediastinal lymph nodes from patients with lung disease and mediastinal lymph node involvement in order to: (1) develop a better understanding of the cause and development of lung disorders involving the mediastinal lymph nodes; (2) identify… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Disease, Inflammation, Lung Cancer
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2011to 16 Feb 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.
Who may be able to join
- Must provide informed consent
- Males and females, age 18 years and older
- Lung disease proven by at least one of the following:
- symptoms consistent with pulmonary disease
- chest X-ray and chest CT and/or PET CT scan consistent with lung disease and mediastinal lymph node involvement
- lung biopsy consistent with lung disease known to involve mediastinal lymph nodes
- patients with diseases of organs with known association to lung disease and mediastinal lymph node involvement.
- Undergoing fiberoptic bronchoscopy with EBUS-TBNA as dictated by their standard clinical care
Who cannot join
- Patient refuses consent.
- Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, or any local anesthetic will not be included in the study
- Individuals who cannot tolerate general anesthesia or moderate sedation and analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, 10021
About this study
Official title: Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases
The purpose of this protocol is to obtain biologic materials from the mediastinal lymph nodes from patients with lung disease and mediastinal lymph node involvement in order to: (1) develop a better understanding of the cause and development of lung disorders involving the mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict the behavior of human lung diseases; and (3) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs.
Read the detailed description
This study will use bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) as part of their diagnostic work up as recommended by the treating physician. The procedure will be performed as standard of care, either under general anesthesia in the operating room or in the bronchoscopy suite under moderate sedation and analgesia. Bronchoscopy with EBUS-TBNA is normally an ambulatory procedure. During the procedure, biopsy needle will be passed through the tube and a small sample will be taken for both diagnostic and research purposes. Samples collected for diagnostic purposes will be sent to the Department of Pathology. Additional biopsy samples will be collected for research purposes. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. All subjects will be discharged with an escort as per Hospital policy. An overnight stay would be required for ambulatory individuals only if the individual is not, in the judgment of the treating attending physician, safe to be discharged as is standard practice.
- Conditions
- Lung Disease, Inflammation, Lung Cancer, Sarcoidosis
- Keywords
- lung disease, mediastinal lymph node, bronchoscopy, Endobronchial-Guided Transbronchial Needle Aspiration
- Medical subject headings
- Lung Diseases, Inflammation, Lung Neoplasms, Sarcoidosis
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 |
|---|---|---|
| Patients with lung disease | General admission criteria for this project will require at least one of the following: (1) symptoms consistent with pulmonary disease with mediastinal lymph node involvement ; (2) chest X-ray and chest CT scan consistent with lung disease and mediastinal lymph node involvement; (3) Individuals with a lung biopsy consistent with lung disease and presenting with enlarged mediastinal lymph nodes; and (4) patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes
Bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study start16 Aug 2011
- Primary completion6 Feb 2017
- Study completion16 Feb 2017
Why it stopped: Study was terminated due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben-Gary Harvey, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168036
- Sponsor's protocol ID
- 1104011629
- Status last verified
- Dec 2017
- First submitted
- 17 Jun 2014
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases
- ClinicalTrials.gov ID
- NCT02168036
- Acronym / sponsor ID
- 1104011629
- Conditions
- Lung Disease, Inflammation, Lung Cancer, Sarcoidosis
- Keywords
- lung disease, mediastinal lymph node, bronchoscopy, Endobronchial-Guided Transbronchial Needle Aspiration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 16 Aug 2011 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 19 Jun 2014 (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 protocol is to obtain biologic materials from the mediastinal lymph nodes from patients with lung disease and mediastinal lymph node involvement in order to: (1) develop a better understanding of the cause and development of lung disorders involving the mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict the behavior of human lung diseases; and (3) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs.
Detailed description
This study will use bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) as part of their diagnostic work up as recommended by the treating physician. The procedure will be performed as standard of care, either under general anesthesia in the operating room or in the bronchoscopy suite under moderate sedation and analgesia. Bronchoscopy with EBUS-TBNA is normally an ambulatory procedure. During the procedure, biopsy needle will be passed through the tube and a small sample will be taken for both diagnostic and research purposes. Samples collected for diagnostic purposes will be sent to the Department of Pathology. Additional biopsy samples will be collected for research purposes. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. All subjects will be discharged with an escort as per Hospital policy. An overnight stay would be required for ambulatory individuals only if the individual is not, in the judgment of the treating attending physician, safe to be discharged as is standard practice.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung disease | – | –General admission criteria for this project will require at least one of the following: (1) symptoms consistent with pulmonary disease with mediastinal lymph node involvement ; (2) chest X-ray and chest CT scan consistent with lung disease and mediastinal lymph node involvement; (3) Individuals with a lung biopsy consistent with lung disease and presenting with enlarged mediastinal lymph nodes; and (4) patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.
Key inclusion criteria (8 listed)
- Must provide informed consent
- Males and females, age 18 years and older
- Lung disease proven by at least one of the following:
- Undergoing fiberoptic bronchoscopy with EBUS-TBNA as dictated by their standard clinical care
Key exclusion criteria (3 listed)
- Patient refuses consent.
- Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, or any local anesthetic will not be included in the study
- Individuals who cannot tolerate general anesthesia or moderate sedation and analgesia
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
Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes
Time frame: 24 Hours
Bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ben-Gary Harvey, MD principal investigator
Weill Medical College of Cornell University
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 Lung Disease and Inflammation, run by Weill Medical College of Cornell University at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 26 Dec 2017. 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 United States. 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 stopped early (reason given: Study was terminated due to lack of funding.). 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?
Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes (time frame: 24 Hours). 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 26 Dec 2017.