<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/NCT02986048</url>
  </required_header>
  <id_info>
    <org_study_id>CASE4Y16</org_study_id>
    <nct_id>NCT02986048</nct_id>
  </id_info>
  <brief_title>Proton Therapy Patient Registry</brief_title>
  <official_title>Proton Therapy Patient Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case 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>
      The purpose of this study is to establish a database (or &quot;registry&quot;) of patients treated with&#xD;
      proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track&#xD;
      of the patients treated it will allow the investigators to periodically evaluate the outcomes&#xD;
      of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this non-therapeutic registry study is to create a secure&#xD;
      longitudinal database of patients treated with proton therapy at the UH Proton Therapy&#xD;
      Center. This will allow reporting patient, tumor, and treatment characteristics as well as&#xD;
      outcome data pertaining to disease control and complications for this relatively rare&#xD;
      radiation modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 22, 2016</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Number of participants treated at UH Proton Therapy Center by proton beam therapy</measure>
    <time_frame>Up to 10 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">999</enrollment>
  <condition>Treatment With Proton Beam Radiation Therapy</condition>
  <arm_group>
    <arm_group_label>Proton Beam Therapy</arm_group_label>
    <description>All patients treated with proton beam therapy at the UH Proton Therapy Center who consent to have their health information recorded, including whether the cancer was cured and if any complications occur ed due to treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proton Beam Therapy</intervention_name>
    <description>Intervention is not assigned. Only patient data is being collected</description>
    <arm_group_label>Proton Beam Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated with proton beam at the UH Proton Therapy Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients treated with proton beam at the UH Proton Therapy Center&#xD;
&#xD;
          -  Patients who have the ability to understand and be willing to sign a written informed&#xD;
             consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients or legal guardians who are unable to understand informed consent document&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David B Mansur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David B Mansur, MD</last_name>
    <phone>1-800-641-2422</phone>
    <email>CTUReferral@UHhospitals.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David B Mansur, MD</last_name>
      <phone>800-641-2422</phone>
      <email>CTUReferral@UHhospitals.org</email>
    </contact>
    <investigator>
      <last_name>David B Mansur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>proton beam</keyword>
  <keyword>registry</keyword>
  <keyword>radiation</keyword>
  <keyword>cancer</keyword>
  <!-- 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/NCT02986048
org study id: CASE4Y16
nct id: NCT02986048
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to establish a database (or "registry") of patients treated with
      proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track
      of the patients treated it will allow the investigators to periodically evaluate the outcomes
      of patients.
The primary objective of this non-therapeutic registry study is to create a secure
      longitudinal database of patients treated with proton therapy at the UH Proton Therapy
      Center. This will allow reporting patient, tumor, and treatment characteristics as well as
      outcome data pertaining to disease control and complications for this relatively rare
      radiation modality.
observational model: Cohort
time perspective: Prospective
measure: Number of participants treated at UH Proton Therapy Center by proton beam therapy
time frame: Up to 10 years
arm group label: Proton Beam Therapy
description: All patients treated with proton beam therapy at the UH Proton Therapy Center who consent to have their health information recorded, including whether the cancer was cured and if any complications occur ed due to treatment
intervention type: Other
intervention name: Proton Beam Therapy
description: Intervention is not assigned. Only patient data is being collected
arm group label: Proton Beam Therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David B Mansur, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
last name: David B Mansur, MD
phone: 1-800-641-2422
email: CTUReferral@UHhospitals.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor