Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis

NCT00705848 | Completed DMC

• 1 other identifier: 2007P000336
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small pieces of tissue) and brushings (to collect the cells that form the lining of the airway) from the airways of patients with these diseases and analyze these samples in a laboratory to try and determine the mechanism of disease. We will compare the results with that of patients with normal airways.

Conditions

Tracheobronchomalacia; Tracheal Stenosis

Keywords

trachea; malacia; stenosis

Study Arms (3)

1

10 patients with tracheobronchomalacia

2

10 patients with tracheal stenosis

3

10 patients with normal airways (no known airway diseases)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with tracheobronchomalacia or tracheal stenosis referred to this tertiary care facility

You may qualify if:

• (study group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.
• (control group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.

You may not qualify if:

• (study group): pre-existing airway disorders other than tracheobronchomalacia or subglottic stenosis, etiology of subglottic stenosis other than idiopathic or post-intubation, pulmonary vascular disease, inability to tolerate intravenous conscious sedation.
• (control group): any pre-existing airway disorder, pulmonary vascular disease, and inability to tolerate intravenous conscious sedation.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Airway biopsies and brushings are to be used for staining and culture, respectively

MeSH Terms

Conditions

Tracheobronchomalacia; Tracheal Stenosis; Tracheal Diseases; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sidhu Gangadharan, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)