Clinical trial NCT02168036: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Disease
Inflammation
Lung Cancer
Sarcoidosis
Keywords: lung disease
mediastinal lymph node
bronchoscopy
Endobronchial-Guided Transbronchial Needle Aspiration
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.

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.

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

Primary outcomes:
measure: Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ben-Gary Harvey, MD
role: PRINCIPAL_INVESTIGATOR
References: