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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

Tracking Information
First Submitted Date June 17, 2014
First Posted Date June 19, 2014
Last Update Posted Date December 26, 2017
Actual Study Start Date August 16, 2011
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2014)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Biologic Materials From the Mediastinal Lymph Nodes From Patients With Lung Disease.
Official Title Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Mediastinal tissue/ Lung biological samples
Sampling Method Probability Sample
Study Population Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.
Condition
  • Lung Disease
  • Inflammation
  • Lung Cancer
  • Sarcoidosis
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: December 21, 2017)
56
Original Estimated Enrollment
 (submitted: June 17, 2014)
100
Actual Study Completion Date February 16, 2017
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02168036
Other Study ID Numbers 1104011629
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Ben-Gary Harvey, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2017