<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/NCT04429204</url>
  </required_header>
  <id_info>
    <org_study_id>19-001175</org_study_id>
    <secondary_id>NCI-2020-00640</secondary_id>
    <secondary_id>19-001175</secondary_id>
    <nct_id>NCT04429204</nct_id>
  </id_info>
  <brief_title>Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma</brief_title>
  <official_title>Evaluation of Cryo-Immune Stimulation in Mesothelioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial evaluates if cryoablation will stimulate a local immune response by cluster of&#xD;
      differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of&#xD;
      the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy&#xD;
      tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low&#xD;
      survival rates. The information learned from this study may provide evidence as to whether&#xD;
      there is a measurable, local immune response from cryoablation. Studying samples of&#xD;
      mesothelioma tissue in the laboratory from patients who have undergone biopsy may help&#xD;
      doctors learn more about the effects of cryoablation on cells. It may also help doctors&#xD;
      understand how well patients respond to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local&#xD;
      tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will&#xD;
      not be present in ablation naive regions of the tumors.&#xD;
&#xD;
      II. To determine whether there is a preponderance of T cells in ablated tumor tissue in&#xD;
      comparison to non-cryoablated tissue.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      At the time of standard of care pleural biopsy, patients undergo cryoablation over 30&#xD;
      minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative&#xD;
      control) region are collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was not opened&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells</measure>
    <time_frame>After cryoablation of mesothelioma up to 1 year</time_frame>
    <description>Will be tested by cryoablating a small region of tumor at the time of pleural biopsy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Subsequent fluorescence activated cell sorting for cluster of differentiation 4 positive (CD4+) and CD8+ markers will be performed to identify sub-populations of lymphocytes. The counts will be compared using a one-way paired t-test (two samples from each patient; ablated and non-ablated). The isolated cells will be frozen for potential subsequent use (if the hypothesis for the study is true then subsequent profiling of the cells will be performed, such whole exome sequencing (ribonucleic acid-sequencing) and metabolomic profiling).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mesothelioma</condition>
  <arm_group>
    <arm_group_label>Basic science (cryoablation, tissue collection)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of tissue</description>
    <arm_group_label>Basic science (cryoablation, tissue collection)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryosurgery</intervention_name>
    <description>Undergo cryoablation</description>
    <arm_group_label>Basic science (cryoablation, tissue collection)</arm_group_label>
    <other_name>Ablation, Cryo</other_name>
    <other_name>Cryoablation</other_name>
    <other_name>cryosurgical ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults that have been identified at tumor board with high suspicion for mesothelioma&#xD;
             and are anticipated to be surgical candidates, as determined/discussed at Mesothelioma&#xD;
             Tumor Board&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that have a questionable diagnosis of mesothelioma (i.e. there are other&#xD;
             potentially more likely considerations in the differential diagnosis) or in patients&#xD;
             that would not be expected to be good surgical candidates&#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>Neema Jamshidi</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</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/NCT04429204
org study id: 19-001175
secondary id: NCI-2020-00640
secondary id: 19-001175
nct id: NCT04429204
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial evaluates if cryoablation will stimulate a local immune response by cluster of
      differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of
      the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy
      tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low
      survival rates. The information learned from this study may provide evidence as to whether
      there is a measurable, local immune response from cryoablation. Studying samples of
      mesothelioma tissue in the laboratory from patients who have undergone biopsy may help
      doctors learn more about the effects of cryoablation on cells. It may also help doctors
      understand how well patients respond to treatment.
PRIMARY OBJECTIVES:

      I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local
      tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will
      not be present in ablation naive regions of the tumors.

      II. To determine whether there is a preponderance of T cells in ablated tumor tissue in
      comparison to non-cryoablated tissue.

      OUTLINE:

      At the time of standard of care pleural biopsy, patients undergo cryoablation over 30
      minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative
      control) region are collected.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells
time frame: After cryoablation of mesothelioma up to 1 year
description: Will be tested by cryoablating a small region of tumor at the time of pleural biopsy.
measure: Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue
time frame: Up to 1 year
description: Subsequent fluorescence activated cell sorting for cluster of differentiation 4 positive (CD4+) and CD8+ markers will be performed to identify sub-populations of lymphocytes. The counts will be compared using a one-way paired t-test (two samples from each patient; ablated and non-ablated). The isolated cells will be frozen for potential subsequent use (if the hypothesis for the study is true then subsequent profiling of the cells will be performed, such whole exome sequencing (ribonucleic acid-sequencing) and metabolomic profiling).
arm group label: Basic science (cryoablation, tissue collection)
arm group type: Experimental
description: At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of tissue
arm group label: Basic science (cryoablation, tissue collection)
intervention type: Procedure
intervention name: Cryosurgery
description: Undergo cryoablation
arm group label: Basic science (cryoablation, tissue collection)
other name: Ablation, Cryo
other name: Cryoablation
other name: cryosurgical ablation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Neema Jamshidi
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant