<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/NCT02235779</url>
  </required_header>
  <id_info>
    <org_study_id>CryobiopsieTBB</org_study_id>
    <nct_id>NCT02235779</nct_id>
  </id_info>
  <brief_title>Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases</brief_title>
  <official_title>DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies&#xD;
      done via bronchoscopy in the investigation of interstitial lung disease in comparison with&#xD;
      videothoracoscopy-assisted surgical lung biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease</measure>
    <time_frame>After biopsy (up to 24 months)</time_frame>
    <description>Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate of transbronchial cryobiopsy procedure</measure>
    <time_frame>Per-procedure and up to 24 hours after</time_frame>
    <description>Assessment of complications related to cryoTBB:&#xD;
pneumothorax&#xD;
hemorrage&#xD;
other complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen</measure>
    <time_frame>After biopsy (up to 24 months)</time_frame>
    <description>Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-observer agreement for cryobiopsy specimens</measure>
    <time_frame>After biopsy (up to 24 months)</time_frame>
    <description>Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Size of cryobiopsy specimen</measure>
    <time_frame>After biopsy (up to 24months)</time_frame>
    <description>Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of cyrobiopsy specimens</measure>
    <time_frame>After biopsy (up to 24 months)</time_frame>
    <description>Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Cryobiopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transbronchial lung cryobiopsy</intervention_name>
    <arm_group_label>Cryobiopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is&#xD;
             planned for diagnostic investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged less than 18 y.o.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known coagulatoin disorder or blood dyscrasia&#xD;
&#xD;
          -  Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that&#xD;
             cannot be safely discontinued to undergo lung biopsy&#xD;
&#xD;
          -  Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen&#xD;
&#xD;
          -  Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine Delage, MDCM</last_name>
    <role>Study Chair</role>
    <affiliation>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antoine Delage, MDCM</last_name>
    <phone>418-656-4747</phone>
    <email>antoine.delage@criucpq.ulaval.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut universitaire de cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Delage, MDCM</last_name>
      <phone>418-656-4747</phone>
      <email>antoine.delage@criucpq.ulaval.ca</email>
    </contact>
    <investigator>
      <last_name>Antoine Delage, MDCM</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simon Martel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Steeve Provencher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Genevieve Dion, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Philippe Joubert, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Massimo Conti, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paula Ugalde, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ILD</keyword>
  <keyword>Pulmonary fibrosis</keyword>
  <keyword>Cryobiopsy</keyword>
  <keyword>Transbronchial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT02235779
org study id: CryobiopsieTBB
nct id: NCT02235779
lead sponsor: 
has dmc: No
Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies
      done via bronchoscopy in the investigation of interstitial lung disease in comparison with
      videothoracoscopy-assisted surgical lung biopsy.
See above
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
time frame: After biopsy (up to 24 months)
description: Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.
measure: Complication rate of transbronchial cryobiopsy procedure
time frame: Per-procedure and up to 24 hours after
description: Assessment of complications related to cryoTBB:
pneumothorax
hemorrage
other complications
measure: Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen
time frame: After biopsy (up to 24 months)
description: Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe)
measure: Inter-observer agreement for cryobiopsy specimens
time frame: After biopsy (up to 24 months)
description: Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.
measure: Size of cryobiopsy specimen
time frame: After biopsy (up to 24months)
description: Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.
measure: Quality of cyrobiopsy specimens
time frame: After biopsy (up to 24 months)
description: Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.
arm group label: Cryobiopsy
arm group type: Other
intervention type: Other
intervention name: Transbronchial lung cryobiopsy
arm group label: Cryobiopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine Delage, MDCM
role: Study Chair
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
last name: Antoine Delage, MDCM
phone: 418-656-4747
email: antoine.delage@criucpq.ulaval.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial