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Study of Biologic Materials From the Mediastinal Lymph Nodes From Patients With Lung Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168036
Recruitment Status : Terminated (Study was terminated due to lack of funding.)
First Posted : June 19, 2014
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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 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.

Condition or disease
Lung Disease Inflammation Lung Cancer Sarcoidosis

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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases
Actual Study Start Date : August 16, 2011
Actual Primary Completion Date : February 6, 2017
Actual Study Completion Date : February 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort
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.



Primary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples With DNA
Mediastinal tissue/ Lung biological samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.
Criteria

Inclusion Criteria:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Lung disease proven by at least one of the following:

    1. symptoms consistent with pulmonary disease
    2. chest X-ray and chest CT and/or PET CT scan consistent with lung disease and mediastinal lymph node involvement
    3. lung biopsy consistent with lung disease known to involve mediastinal lymph nodes
    4. 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168036


Locations
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United States, New York
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Ben-Gary Harvey, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02168036    
Other Study ID Numbers: 1104011629
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weill Medical College of Cornell University:
lung disease
mediastinal lymph node
bronchoscopy
Endobronchial-Guided Transbronchial Needle Aspiration
Additional relevant MeSH terms:
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Lung Diseases
Sarcoidosis
Inflammation
Pathologic Processes
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases