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

Lung Cancer Clinical Trial

Official title:

Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02168036
• Other study ID #: 1104011629
• Status: Terminated
• Phase: N/A
• First received: June 17, 2014
• Last updated: December 21, 2017
• Start date: August 16, 2011
• Est. completion date: February 16, 2017

Study information

• Verified date: December 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: February 16, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Lung Cancer
• Lung Disease
• Lung Diseases
• Sarcoidosis

Locations

Country	Name	City	State
United States	Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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