<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/NCT02259218</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-11108</org_study_id>
    <secondary_id>NCI-2014-01575</secondary_id>
    <nct_id>NCT02259218</nct_id>
  </id_info>
  <brief_title>Longitudinal Metabolomic and Epigenetic Profiling of Bodyfluids From Patients With Lung and Brain Cancer Receiving Radiation Therapy</brief_title>
  <official_title>Biomarker Discovery for Toxicity and Survival in Radiation Oncology: An Integrative Molecular-Clinical Approach</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>Yes</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 research trial studies metabolomic and other molecular profiling to identify predictive&#xD;
      biomarkers for radiation toxicity and survival in patients with lung or brain cancers&#xD;
      receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with&#xD;
      lung or brain cancer in the laboratory may help doctors identify and learn more about&#xD;
      biomarkers related to cancer and predict which patients are at higher risk for developing&#xD;
      radiation side effects and how well patients will respond to radiation treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation&#xD;
      therapy for lung cancer associated with the development of radiation pneumonitis.&#xD;
&#xD;
      II. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation&#xD;
      therapy for brain cancer associated with the development of radiation necrosis.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing&#xD;
      radiation therapy for lung and brain cancer associated with survival.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and&#xD;
      epigenetic profiling using massspectrometry, array, and sequencing-based technology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 4, 2012</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients</measure>
    <time_frame>Baseline</time_frame>
    <description>For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients</measure>
    <time_frame>Baseline</time_frame>
    <description>For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis</measure>
    <time_frame>Baseline</time_frame>
    <description>Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">273</enrollment>
  <condition>Adult Brain Tumor</condition>
  <condition>Lung Cancer</condition>
  <condition>Radiation Toxicity</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative</arm_group_label>
    <description>Prospectively collected blood, urine, and tissue samples are analyzed for potential predictive biomarkers via metabolomic and other molecular profiling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine, tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with lung, brain, prostate or cervical cancer that are being treated&#xD;
        with radiation therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consultation with the Radiation Oncology department of the Ohio State University (OSU)&#xD;
             Comprehensive Cancer Center&#xD;
&#xD;
          -  The following diagnoses will be included: malignant neoplasm of the brain; primary&#xD;
             malignant neoplasm of trachea bronchus and lung; primary malignant neoplasm of the&#xD;
             cervix uteri and primary malignant neoplasm the prostate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being an inmate&#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>Arnab Chakravarti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</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>Arnab Chakravarti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Biomarker</keyword>
  <keyword>Radiation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02259218
org study id: OSU-11108
secondary id: NCI-2014-01575
nct id: NCT02259218
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research trial studies metabolomic and other molecular profiling to identify predictive
      biomarkers for radiation toxicity and survival in patients with lung or brain cancers
      receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with
      lung or brain cancer in the laboratory may help doctors identify and learn more about
      biomarkers related to cancer and predict which patients are at higher risk for developing
      radiation side effects and how well patients will respond to radiation treatment.
PRIMARY OBJECTIVES:

      I. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation
      therapy for lung cancer associated with the development of radiation pneumonitis.

      II. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation
      therapy for brain cancer associated with the development of radiation necrosis.

      SECONDARY OBJECTIVES:

      I. Metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing
      radiation therapy for lung and brain cancer associated with survival.

      OUTLINE:

      Collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and
      epigenetic profiling using massspectrometry, array, and sequencing-based technology.
observational model: Case-Control
time perspective: Retrospective
measure: Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients
time frame: Baseline
description: For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).
measure: Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients
time frame: Baseline
description: For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).
measure: Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis
time frame: Baseline
description: Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.
arm group label: Ancillary-Correlative
description: Prospectively collected blood, urine, and tissue samples are analyzed for potential predictive biomarkers via metabolomic and other molecular profiling.
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Ancillary-Correlative
Blood, urine, tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnab Chakravarti, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
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: Arnab Chakravarti
investigator title: Principal Investigator
sharing ipd: No