Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

International Plastic Bronchitis Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01663948
First received: August 9, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.


Condition
Plastic Bronchitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Plastic Bronchitis Registry

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • natural course and long term health outcomes [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    The purpose of the intrnational plastic bronchitis registry is to understand the natural course and long term health outcomes of patients diagnosed with plastic bronchitis. This provides essential data for identifying possible causes of this disease and potential treatments.


Biospecimen Retention:   Samples With DNA

Airway Casts


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Plastic bronchitis

Detailed Description:

Plastic bronchitis (PB) patients have casts removed during bronchoscopy as part of their routine care or that they are able to expectorate (cough out) casts naturally. The casts are normally discarded. Patients that agree to participate in the registry ship the airway casts and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth University Richmond Virginia, USA.

The lab evaluates the biopolymer composition and structure of the airway casts by immunohistochemistry in order to identify microscopic differences between expectorated casts of subjects with plastic bronchitis and sputum from other populations (cystic fibrosis,chronic obstructive pulmonary disease , and normal airways). The lab also conducts in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator concentrations to better understand the nature of the disease.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study is open to patients around the world suffering from Plastic bronchitis

Criteria

Inclusion Criteria:

  • Diagnosed with Plastic bronchitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663948

Contacts
Contact: Jennifer L Bradley, B.A 804-628-2793 jlbradley@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Jennifer L Bradley, B.A    8046282793    jlbradley@vcu.edu   
Principal Investigator: Bruce k Rubin, MEngr, MD, MBA, FRCPC         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Bruce K Rubin, MEngr, MD, MBA, FRCPC Children's Hospital of Richmond at VCU
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01663948     History of Changes
Other Study ID Numbers: HM14554
Study First Received: August 9, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Plastic bronchitis
PB

Additional relevant MeSH terms:
Acute Disease
Bronchitis
Bronchial Diseases
Disease Attributes
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 27, 2014