<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01663948</url>
  </required_header>
  <id_info>
    <org_study_id>HM14554</org_study_id>
    <nct_id>NCT01663948</nct_id>
  </id_info>
  <brief_title>International Plastic Bronchitis Registry</brief_title>
  <official_title>International Plastic Bronchitis Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the international plastic bronchitis registry is to understand the natural&#xD;
      course and long term health outcomes of subjects diagnosed with plastic bronchitis due to&#xD;
      different types of casts. This provides essential data for identifying best practices and&#xD;
      treatments. The secondary aim is to understand the structure of casts and mechanism of their&#xD;
      formation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plastic bronchitis (PB) patients have casts removed during bronchoscopy as part of their&#xD;
      routine care or that they are able to expectorate (cough out) casts naturally. The casts are&#xD;
      normally discarded. Patients that agree to participate in the registry ship the airway casts&#xD;
      and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth&#xD;
      University Richmond Virginia, USA.&#xD;
&#xD;
      The lab evaluates the biopolymer composition and structure of the airway casts by&#xD;
      immunohistochemistry in order to identify microscopic differences between expectorated casts&#xD;
      of subjects with plastic bronchitis and sputum from other populations (cystic&#xD;
      fibrosis,chronic obstructive pulmonary disease , and normal airways). The lab also conducts&#xD;
      in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator&#xD;
      concentrations to better understand the nature of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Loss of staff combined with low study enrollment and a change in lab/PI priorities&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>natural course and long term health outcomes</measure>
    <time_frame>ongoing</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Plastic Bronchitis</condition>
  <arm_group>
    <arm_group_label>Patients with Plastic bronchitis</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Airway Casts&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study is open to patients around the world suffering from Plastic bronchitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Plastic bronchitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce K Rubin, MEngr, MD, MBA, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Richmond at VCU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Plastic bronchitis</keyword>
  <keyword>PB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01663948
org study id: HM14554
nct id: NCT01663948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: natural course and long term health outcomes
time frame: ongoing
description: 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.
arm group label: Patients with Plastic bronchitis
Airway Casts
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bruce K Rubin, MEngr, MD, MBA, FRCPC
role: Principal Investigator
affiliation: Children's Hospital of Richmond at VCU
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bronchitis
mesh term: Acute Disease