<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/NCT01694615</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00052081</org_study_id>
    <nct_id>NCT01694615</nct_id>
  </id_info>
  <brief_title>Cryoprobe Transbronchial Lung Biopsy in Lung Transplant Patients</brief_title>
  <official_title>Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and&#xD;
      for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.&#xD;
      It is recognized that standard forceps biopsies underestimate the presence or degree of&#xD;
      airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been&#xD;
      shown in the literature to provide larger samples without crush artifact in a safe fashion in&#xD;
      lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is&#xD;
      superior to standard transbronchial forceps biopsies in regards to sample size, architecture&#xD;
      and the diagnosis of early rejection in lung transplant recipients which if discovered&#xD;
      earlier may improve survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)</measure>
    <time_frame>From date of study enrollment until the patient is 2 years post lung transplant</time_frame>
    <description>Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)</measure>
    <time_frame>From date of study enrollment until the patient is 2 years post lung transplant</time_frame>
    <description>Each specimen will be independently reviewed by a lung transplant pathology physician to determine the presence or absence of rejection and results compared. All data will be available to the transplant team in the event any rejection is found, it will be acted upon immediately as per the transplant teams protocol.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lung Transplantation</condition>
  <arm_group>
    <arm_group_label>Cryoprobe biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forceps Biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoprobe biopsy</intervention_name>
    <arm_group_label>Cryoprobe biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Forceps Biopsy</intervention_name>
    <arm_group_label>Forceps Biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals referred for either clinically indicated or surveillance flexible&#xD;
             bronchoscopy will be included in the study population&#xD;
&#xD;
          -  Age greater than 18 years and having undergone bilateral orthotopic lung&#xD;
             transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy: plts &lt; 50,000 international normalized ratio (INR) &gt; 1.5&#xD;
&#xD;
          -  Forced expiratory volume at one second (FEV1) &lt; 0.8&#xD;
&#xD;
          -  Diffuse bullous disease&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Severe hypoxemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lonny Yarmus</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.hopkinsmedicine.org/ip</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>October 3, 2016</last_update_submitted>
  <last_update_submitted_qc>October 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Transplantation</keyword>
  <keyword>Acute Rejection</keyword>
  <!-- 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/NCT01694615
org study id: NA_00052081
nct id: NCT01694615
lead sponsor: 
has dmc: Yes
Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and
      for surveillance in the diagnosis of acute rejection using standard transbronchial forceps.
      It is recognized that standard forceps biopsies underestimate the presence or degree of
      airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been
      shown in the literature to provide larger samples without crush artifact in a safe fashion in
      lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is
      superior to standard transbronchial forceps biopsies in regards to sample size, architecture
      and the diagnosis of early rejection in lung transplant recipients which if discovered
      earlier may improve survival.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)
time frame: From date of study enrollment until the patient is 2 years post lung transplant
description: Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue.
measure: Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)
time frame: From date of study enrollment until the patient is 2 years post lung transplant
description: Each specimen will be independently reviewed by a lung transplant pathology physician to determine the presence or absence of rejection and results compared. All data will be available to the transplant team in the event any rejection is found, it will be acted upon immediately as per the transplant teams protocol.
arm group label: Cryoprobe biopsy
arm group type: Active Comparator
description: All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
arm group label: Forceps Biopsy
arm group type: Active Comparator
description: All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
intervention type: Procedure
intervention name: Cryoprobe biopsy
arm group label: Cryoprobe biopsy
intervention type: Procedure
intervention name: Forceps Biopsy
arm group label: Forceps Biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Lonny Yarmus
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
url: http://www.hopkinsmedicine.org/ip
description: Related Info
responsible party type: Sponsor