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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT02168036

Collaborator

(none)

Enrollment

Location

66.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Aug 16, 2011

Actual Primary Completion Date :

Feb 6, 2017

Actual Study Completion Date :

Feb 16, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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