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/NCT06031194</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-22305</org_study_id>
      <secondary_id>NCI-2023-03467</secondary_id>
      <nct_id>NCT06031194</nct_id>
    </id_info>
    <brief_title>Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma</brief_title>
    <official_title>Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University Comprehensive Cancer Center</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 evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients&#xD;
        with diffuse large B-cell lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To identify SNPs associated with delayed MTX clearance. II. To explore any association&#xD;
        between SNPs and increased toxicity.&#xD;
  &#xD;
        OUTLINE: This is an observational study.&#xD;
  &#xD;
        Participants undergo blood sample collection and have their medical records reviewed on&#xD;
        study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>SNPs associated with delayed MTX clearance</measure>
      <time_frame>Up to 24 weeks</time_frame>
      <description>Determine the SNPs associated with delayed methotrexate clearance</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Central Nervous System Lymphoma</condition>
    <condition>Diffuse Large B-Cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Observational</arm_group_label>
      <description>Participants undergo blood sample collection and have their medical records reviewed on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non-Interventional Study</intervention_name>
      <description>Non-interventional study</description>
      <arm_group_label>Observational</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with DLBCL or primary CNS lymphoma planned to undergo treatment with HDMTX (≥ 3&#xD;
          g/m^2) at the James Cancer Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  * Adult (age ≥ 18 years at diagnosis)&#xD;
  &#xD;
                 -  Diagnosis of DLBCL or PCNSL&#xD;
  &#xD;
                 -  Planned to undergo treatment with HDMTX (≥ 3 g/m^2) at the James Cancer Hospital.&#xD;
  &#xD;
          Note: patients with CKD are eligible to participate regardless of eGFR provided the&#xD;
          treating physician is planning a dose of HDMTX of at least 3 g/ m^2.&#xD;
  &#xD;
            -  Ability to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  * Patients with a &quot;currently active&quot; second malignancy that, in the opinion of the&#xD;
               principal investigator, will interfere with patient participation, or confound data&#xD;
               interpretation&#xD;
  &#xD;
                 -  Pregnancy (positive serum or urine pregnancy test), lactating or breast feeding&#xD;
  &#xD;
                 -  Prisoners or incarcerated patients&#xD;
  &#xD;
                 -  Total bilirubin &gt; 5 mg/dL&#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>Narendranath Epperla, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State Comprehensive Cancer Center</last_name>
      <phone>800-293-5066</phone>
      <email>OSUCCCClinicaltrials@osumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ohio State University Comprehensive Cancer Center</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Narendranath Epperla, MD, MS</last_name>
        <phone>614-688-7940</phone>
        <email>Narendranath.Epperla@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Narendranath Epperla, MD, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://cancer.osu.edu</url>
      <description>The Jamesline</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
      <investigator_full_name>Narendranath Epperla</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06031194
  org study id: OSU-22305
  secondary id: NCI-2023-03467
  nct id: NCT06031194
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients
        with diffuse large B-cell lymphoma.
  PRIMARY OBJECTIVES:
  
        I. To identify SNPs associated with delayed MTX clearance. II. To explore any association
        between SNPs and increased toxicity.
  
        OUTLINE: This is an observational study.
  
        Participants undergo blood sample collection and have their medical records reviewed on
        study.
  observational model: Cohort
  time perspective: Prospective
  measure: SNPs associated with delayed MTX clearance
  time frame: Up to 24 weeks
  description: Determine the SNPs associated with delayed methotrexate clearance
  arm group label: Observational
  description: Participants undergo blood sample collection and have their medical records reviewed on study.
  intervention type: Other
  intervention name: Non-Interventional Study
  description: Non-interventional study
  arm group label: Observational
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Narendranath Epperla, MD, MS
  role: Principal Investigator
  affiliation: Ohio State University Comprehensive Cancer Center
  last name: The Ohio State Comprehensive Cancer Center
  phone: 800-293-5066
  email: OSUCCCClinicaltrials@osumc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://cancer.osu.edu
  description: The Jamesline
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University Comprehensive Cancer Center
  investigator full name: Narendranath Epperla
  investigator title: Principal Investigator
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse
  sharing ipd: No