Study of Biologic Materials From the Mediastinal Lymph Nodes From Patients With Lung Disease.
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer, Endocrine, Pulmonary |
| Therapuetic Areas: | Endocrinology, Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/27/2017 |
| Start Date: | August 16, 2011 |
| End Date: | February 16, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: Ben-Gary Harvey, MD
Phone: 646-962-4537
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