<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/NCT04410302</url>
  </required_header>
  <id_info>
    <org_study_id>1420270</org_study_id>
    <secondary_id>NCI-2020-01323</secondary_id>
    <secondary_id>1420270-1</secondary_id>
    <secondary_id>P30CA093373</secondary_id>
    <secondary_id>U54CA233306</secondary_id>
    <nct_id>NCT04410302</nct_id>
  </id_info>
  <brief_title>Patient-Derived Xenografts to Reduce Cancer Health Disparities</brief_title>
  <official_title>University of California Minority Patient-Derived Xenograft (PDX) Development and Trial Center (UCaMP) to Reduce Cancer Health Disparities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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 establishes patient-derived cancer xenografts in addressing cancer health and&#xD;
      treatment disparities that disproportionately affect racial/ethnic minorities. Understanding&#xD;
      the genetic and response differences among racial/ethnic minorities may help researchers&#xD;
      enhance the precision of therapeutic treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Develop and characterize over 200 patient-derived xenografts (PDXs), with at least 50 PDXs&#xD;
      each for gastric, liver, bladder, and lung cancers with 60% (approximately) of the PDXs from&#xD;
      minority patients, focusing on Hispanic/Latino Americans [HLAs], African Americans [AAs], and&#xD;
      Asian American/Native Hawaiians/Pacific Islanders [AANHPIs].&#xD;
&#xD;
      II. Utilize these PDXs in preclinical testing of single agents and drug combinations to guide&#xD;
      precision cancer medicine decision-making with a focus upon the predominant racial/ethnic&#xD;
      minority populations residing in California compared to non-Hispanic Whites [NHWs].&#xD;
&#xD;
      III. Conduct &quot;Characterizing Treatment Responses with PDX Models for Gastric and Liver&#xD;
      Tumors&quot; as Research Project 1, focused on the most common histological forms of gastric&#xD;
      cancer (GC) and liver cancers (LC) primarily from HLAs and AANHPI patients.&#xD;
&#xD;
      IV. Conduct &quot;Characterizing Treatment Responses with PDX Models for Lung and Bladder Tumors&quot;&#xD;
      as Research Project 2, focused on lung squamous cell carcinoma (LSCC) and advanced urothelial&#xD;
      or bladder cancer (aBC) primarily from AA and NHW patients.&#xD;
&#xD;
      V. Collaborate with the National Cancer Institute (NCI), other PDX Development and Trial&#xD;
      Centers (PDTCs), non-PDXNet, PDXNet Data Commons and Coordinating Centers to fulfill the&#xD;
      mission of the PDXNet.&#xD;
&#xD;
      VI. Select and conduct pilot projects through the Pilot Projects and Trans-Network Activities&#xD;
      Core (PPTNAC) inclusive of UCaMP members, other PDTCs and beyond that will evaluate&#xD;
      comparative therapeutic responses using PDX models and contribute to the elucidation of&#xD;
      biological determinants of cancer health disparities in gastric, liver, bladder, and lung&#xD;
      cancers.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo collection of tumor tissue samples during standard of care tumor biopsy or&#xD;
      surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva,&#xD;
      and urine samples to compare deoxyribonucleic acid (DNA) abnormalities to noncancer cells in&#xD;
      order to determine if they were present before the cancer started or developed with it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 12, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Establish and characterize at least 200 patient-derived cancer xenografts (PDXs)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>The investigators will establish and characterize at least 200 PDXs, and utilize these PDXs in preclinicial testing of single agents and drug combinations that help guide future clinical decision-making emphasizing the largest racial/ethnic minority populations residing in California: Hispanic/Latino Americans ([HLAs), Asian Americans/Native Hawaiians/Pacific Islanders (AANHIPIs), and African Americans (AAs) compared to Non-Hispanic Whites (NHWs).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Bladder Carcinoma</condition>
  <condition>Gastric Carcinoma</condition>
  <condition>Liver and Intrahepatic Bile Duct Carcinoma</condition>
  <condition>Lung Carcinoma</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Ancillary-correlative (biospecimen collection)</arm_group_label>
    <description>Patients undergo collection of tumor tissue samples during standard of care tumor biopsy or surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva, and urine samples to compare DNA abnormalities to noncancer cells in order to determine if they were present before the cancer started or developed with it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo collection of tumor tissue, blood, saliva, and urine samples</description>
    <arm_group_label>Ancillary-correlative (biospecimen collection)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue, blood, saliva, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with bladder cancer, lung cancer, gastric/stomach cancer, or liver&#xD;
        cancer seen in routine clinic appointments within the University of California (UC) Davis&#xD;
        Health System and contributing University of California Minority PDX (UCaMP) institutions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient receiving treatment for the above 4 cancers (bladder cancer, lung cancer,&#xD;
             gastric/stomach cancer, and liver cancer)&#xD;
&#xD;
          -  Signed informed consent that will be put on file&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No informed consent obtained&#xD;
&#xD;
          -  Specimen unacceptable/degraded/etc.&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Adults unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis G Carvajal-Carmona</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Irvine Health/Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marian Waterman</last_name>
      <phone>949-824-2885</phone>
      <email>marian.waterman@uci.edu</email>
    </contact>
    <investigator>
      <last_name>Marian Waterman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis G. Carvajal-Carmona</last_name>
      <phone>530-752-9654</phone>
      <email>lgcarvajal@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Luis G. Carvajal-Carmona</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</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>Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ductal</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/NCT04410302
org study id: 1420270
secondary id: NCI-2020-01323
secondary id: 1420270-1
secondary id: P30CA093373
secondary id: U54CA233306
nct id: NCT04410302
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This trial establishes patient-derived cancer xenografts in addressing cancer health and
      treatment disparities that disproportionately affect racial/ethnic minorities. Understanding
      the genetic and response differences among racial/ethnic minorities may help researchers
      enhance the precision of therapeutic treatments.
PRIMARY OBJECTIVES:

      I. Develop and characterize over 200 patient-derived xenografts (PDXs), with at least 50 PDXs
      each for gastric, liver, bladder, and lung cancers with 60% (approximately) of the PDXs from
      minority patients, focusing on Hispanic/Latino Americans [HLAs], African Americans [AAs], and
      Asian American/Native Hawaiians/Pacific Islanders [AANHPIs].

      II. Utilize these PDXs in preclinical testing of single agents and drug combinations to guide
      precision cancer medicine decision-making with a focus upon the predominant racial/ethnic
      minority populations residing in California compared to non-Hispanic Whites [NHWs].

      III. Conduct "Characterizing Treatment Responses with PDX Models for Gastric and Liver
      Tumors" as Research Project 1, focused on the most common histological forms of gastric
      cancer (GC) and liver cancers (LC) primarily from HLAs and AANHPI patients.

      IV. Conduct "Characterizing Treatment Responses with PDX Models for Lung and Bladder Tumors"
      as Research Project 2, focused on lung squamous cell carcinoma (LSCC) and advanced urothelial
      or bladder cancer (aBC) primarily from AA and NHW patients.

      V. Collaborate with the National Cancer Institute (NCI), other PDX Development and Trial
      Centers (PDTCs), non-PDXNet, PDXNet Data Commons and Coordinating Centers to fulfill the
      mission of the PDXNet.

      VI. Select and conduct pilot projects through the Pilot Projects and Trans-Network Activities
      Core (PPTNAC) inclusive of UCaMP members, other PDTCs and beyond that will evaluate
      comparative therapeutic responses using PDX models and contribute to the elucidation of
      biological determinants of cancer health disparities in gastric, liver, bladder, and lung
      cancers.

      OUTLINE:

      Patients undergo collection of tumor tissue samples during standard of care tumor biopsy or
      surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva,
      and urine samples to compare deoxyribonucleic acid (DNA) abnormalities to noncancer cells in
      order to determine if they were present before the cancer started or developed with it.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Establish and characterize at least 200 patient-derived cancer xenografts (PDXs)
time frame: Up to 4 years
description: The investigators will establish and characterize at least 200 PDXs, and utilize these PDXs in preclinicial testing of single agents and drug combinations that help guide future clinical decision-making emphasizing the largest racial/ethnic minority populations residing in California: Hispanic/Latino Americans ([HLAs), Asian Americans/Native Hawaiians/Pacific Islanders (AANHIPIs), and African Americans (AAs) compared to Non-Hispanic Whites (NHWs).
arm group label: Ancillary-correlative (biospecimen collection)
description: Patients undergo collection of tumor tissue samples during standard of care tumor biopsy or surgical resection to establish PDXs. Patients may also undergo collection of blood, saliva, and urine samples to compare DNA abnormalities to noncancer cells in order to determine if they were present before the cancer started or developed with it.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo collection of tumor tissue, blood, saliva, and urine samples
arm group label: Ancillary-correlative (biospecimen collection)
Tumor tissue, blood, saliva, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: No
last name: Luis G Carvajal-Carmona
role: Principal Investigator
affiliation: University of California, Davis
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Neoplasms
mesh term: Stomach Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Carcinoma, Ductal