NCT02168036

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
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Disease
• Inflammation
• Lung Cancer
• Sarcoidosis

Timeline

• Start date: 2011-08-16
• Primary completion: 2017-02-06
• Completion: 2017-02-16
• First posted: 2014-06-19
• Last updated: 2017-12-26

Locations

1 site across 1 country: United States