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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02168036

Enrollment

Registered

2014-06-19

Start date

2011-08-16

Completion date

2017-02-16

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Lung Cancer, Lung Disease, Sarcoidosis

Keywords

lung disease, mediastinal lymph node, bronchoscopy, Endobronchial-Guided Transbronchial Needle Aspiration

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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: 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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results