<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/NCT03287349</url>
  </required_header>
  <id_info>
    <org_study_id>16-004880</org_study_id>
    <nct_id>NCT03287349</nct_id>
  </id_info>
  <brief_title>Genomic Assessment of Patients With Severe Radiation Reactions</brief_title>
  <official_title>Genomic Assessment of Patients With Severe Radiation Reactions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood&#xD;
      draw.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Whole exome sequencing</measure>
    <time_frame>baseline</time_frame>
    <description>Investigate genes potentially responsible for severe radiation reactions by getting blood draws.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Radiation; Reaction</condition>
  <arm_group>
    <arm_group_label>Patients with severe reactions to radiation</arm_group_label>
    <description>Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draw</intervention_name>
    <description>Two 12.5 mL blood draws</description>
    <arm_group_label>Patients with severe reactions to radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Photograph</intervention_name>
    <description>Photograph of severe reaction, will be anonymized</description>
    <arm_group_label>Patients with severe reactions to radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Autoimmune testing</intervention_name>
    <description>Autoimmune testing in patients without prior testing</description>
    <arm_group_label>Patients with severe reactions to radiation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adults with severe reactions to radiation treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weigh at least 110 pounds&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly Corbin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kimberly Corbin, M.D.</last_name>
    <phone>507-284-2669</phone>
    <email>Corbin.Kimberly@mayo.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Haen</last_name>
      <phone>855-776-0015</phone>
      <email>haen.jennifer@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kimberly S. Corbin</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <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/NCT03287349
org study id: 16-004880
nct id: NCT03287349
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood
      draw.
observational model: Case-Only
time perspective: Prospective
measure: Whole exome sequencing
time frame: baseline
description: Investigate genes potentially responsible for severe radiation reactions by getting blood draws.
arm group label: Patients with severe reactions to radiation
description: Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing.
intervention type: Other
intervention name: Blood draw
description: Two 12.5 mL blood draws
arm group label: Patients with severe reactions to radiation
intervention type: Other
intervention name: Photograph
description: Photograph of severe reaction, will be anonymized
arm group label: Patients with severe reactions to radiation
intervention type: Diagnostic Test
intervention name: Autoimmune testing
description: Autoimmune testing in patients without prior testing
arm group label: Patients with severe reactions to radiation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kimberly Corbin, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
last name: Kimberly Corbin, M.D.
phone: 507-284-2669
email: Corbin.Kimberly@mayo.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kimberly S. Corbin
investigator title: PI
sharing ipd: No