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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-16

Study Completion Date

2017-02-16

Brief Summary

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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

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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.

Conditions

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Lung Disease Inflammation Lung Cancer Sarcoidosis

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben-Gary Harvey, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1104011629

Identifier Type: -

Identifier Source: org_study_id