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

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Lung Cancer; Lung Disease; 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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with diseases of organs with known association with lung disease and mediastinal lymph node involvement.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes	Bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)	24 Hours

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Ben-Gary Harvey, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2011
• Primary Completion (Actual): February 6, 2017
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: bronchoscopy; mediastinal lymph node; lung disease; Endobronchial-Guided Transbronchial Needle Aspiration
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Inflammation; Sarcoidosis
• Other Study ID Numbers: 1104011629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED