xml: <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/NCT05975593</url>
    </required_header>
    <id_info>
      <org_study_id>202307103</org_study_id>
      <nct_id>NCT05975593</nct_id>
    </id_info>
    <brief_title>MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial</brief_title>
    <acronym>METEOR-CRATR</acronym>
    <official_title>MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</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>
        This study is a dynamically adjustable prospective longitudinal study designed to capture&#xD;
        biospecimen (biopsy, blood, surgical) and multimodal treatment (imaging, dosimetry, clinical)&#xD;
        data before, during, and after treatment with definitive-intent standard of care (SOC)&#xD;
        chemoradiotherapy (CRT) for patients with locally advanced cervical and pancreatic cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2032</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2032</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>Changes in tumor microenvironment</measure>
      <time_frame>From start of follow-up through completion of follow-up (estimated to be 5 years)</time_frame>
      <description>Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Locally Advanced Cervical Carcinoma</condition>
    <condition>Locally Advanced Cervical Cancer</condition>
    <condition>Locally Advanced Pancreas Cancer</condition>
    <condition>Locally Advanced Pancreatic Carcinoma</condition>
    <condition>Locally Advanced Pancreatic Cancer</condition>
    <condition>Cervical Cancer</condition>
    <condition>Pancreas Cancer</condition>
    <condition>Pancreatic Cancer</condition>
    <condition>Cancer of the Cervix</condition>
    <condition>Cancer of the Pancreas</condition>
    <arm_group>
      <arm_group_label>Cervical Cancer</arm_group_label>
      <description>Patients will have blood and tumor collected at various time points throughout participation in the study.&#xD;
  Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pancreatic Cancer</arm_group_label>
      <description>Patients will have blood and tumor collected at various time points throughout participation in the study.&#xD;
  Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood and tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients treated at Siteman Cancer Center that meet the eligibility criteria and sign a&#xD;
          consent to participate in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmation of intent to receive definitive intent standard of care radiotherapy for&#xD;
               one of the following diagnoses:&#xD;
  &#xD;
                 -  Unresectable locally advanced cervical cancer (FIGO stage IB3-IVA)&#xD;
  &#xD;
                 -  Borderline resectable or unresectable locally advanced pancreatic cancer (AJCC&#xD;
                    8th ed stage IB-IV)&#xD;
  &#xD;
            -  ECOG performance status ≤ 2&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
               document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-standard histology (such as small cell or adenocarcinoma for cervical cancer or&#xD;
               neuroendocrine carcinoma for pancreatic cancer)&#xD;
  &#xD;
            -  Co-enrollment to another therapeutic study examining non-standard of care therapy of&#xD;
               any kind&#xD;
  &#xD;
            -  Derangements in coagulation parameters (INR &gt; 1.5 x IULN or aPT &gt; 1.5 x IULN) or known&#xD;
               coagulation disorder that would place the patient at an elevated risk for acquisition&#xD;
               of biospecimens&#xD;
  &#xD;
            -  Any other issue that might preclude safe acquisition of biospecimens&#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>Cliff Robinson, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cliff Robinson, M.D.</last_name>
      <phone>314-362-8567</phone>
      <email>clifford.robinson@wustl.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Cliff Robinson, M.D.</last_name>
        <phone>314-362-8567</phone>
        <email>clifford.robinson@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Cliff Robinson, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Carl DeSelm, M.D., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephanie Markovina, M.D., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Julie Schwarz, M.D., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jessika Contreras, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dineo Khabele, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>David DeNardo, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hyun Kim, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kian-Huat Lim, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ryan Fields, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>William Hawkins, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeff Szymanski, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hua Li, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Albert Lai, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Philip Payne, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Doug Caruthers, M.S.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Esther Lu, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lei Liu, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.siteman.wustl.edu</url>
      <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Radiotherapy</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Cervical cancer</keyword>
    <keyword>Pancreatic cancer</keyword>
    <keyword>Biospecimen</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be presented at scientific meetings &amp; published in journals. Individual-level &amp; aggregate genomic data will be deposited/made available through GEO &amp; SRA. Includes sequence, transcriptomic, epigenomic, &amp; gene expression data. Raw mass spectra &amp; unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE &amp; ProteomeEXchange to share protein identifications &amp; spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH &amp; institutional regulations. BLST will manage &amp; assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Starting with the acceptance date of initial publication.</ipd_time_frame>
      <ipd_access_criteria>Scientific progress and publications will be posted on the METEOR website. The respective departments of the PIs and co-Is also maintain web sites where information and links on the investigators' work are posted. The PIs and co-Is additionally have lab web sites where summaries of the scientific progress on projects and research interests are posted.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975593
  org study id: 202307103
  nct id: NCT05975593
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a dynamically adjustable prospective longitudinal study designed to capture
        biospecimen (biopsy, blood, surgical) and multimodal treatment (imaging, dosimetry, clinical)
        data before, during, and after treatment with definitive-intent standard of care (SOC)
        chemoradiotherapy (CRT) for patients with locally advanced cervical and pancreatic cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: Changes in tumor microenvironment
  time frame: From start of follow-up through completion of follow-up (estimated to be 5 years)
  description: Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.
  arm group label: Cervical Cancer
  description: Patients will have blood and tumor collected at various time points throughout participation in the study.
  Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
  arm group label: Pancreatic Cancer
  description: Patients will have blood and tumor collected at various time points throughout participation in the study.
  Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
  Blood and tissue
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cliff Robinson, M.D.
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Cliff Robinson, M.D.
  phone: 314-362-8567
  email: clifford.robinson@wustl.edu
  facility: 
  contact: 
  investigator: 
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  country: United States
  url: http://www.siteman.wustl.edu
  description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Pancreatic Neoplasms
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: Yes
  ipd description: Data will be presented at scientific meetings & published in journals. Individual-level & aggregate genomic data will be deposited/made available through GEO & SRA. Includes sequence, transcriptomic, epigenomic, & gene expression data. Raw mass spectra & unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE & ProteomeEXchange to share protein identifications & spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH & institutional regulations. BLST will manage & assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Starting with the acceptance date of initial publication.
  ipd access criteria: Scientific progress and publications will be posted on the METEOR website. The respective departments of the PIs and co-Is also maintain web sites where information and links on the investigators' work are posted. The PIs and co-Is additionally have lab web sites where summaries of the scientific progress on projects and research interests are posted.