<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/NCT01696721</url>
  </required_header>
  <id_info>
    <org_study_id>12-103</org_study_id>
    <nct_id>NCT01696721</nct_id>
  </id_info>
  <brief_title>Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy</brief_title>
  <official_title>Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better&#xD;
      results in treating patients with cancer, both because there is better control of where in&#xD;
      the body the radiation is directed and because it is associated with less severe long term&#xD;
      side effects. However, there is limited published data demonstrating these results. The goal&#xD;
      of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with&#xD;
      radiation in order to describe the population that currently receives radiation and better&#xD;
      compare the short-term and long-term benefits of different types of radiotherapy. The data&#xD;
      collected from this study will help facilitate research on radiation therapy and allow for&#xD;
      collaborative research. The PPCR will collect demographic and clinical data that many centers&#xD;
      that deliver radiation therapy already collect in routine operations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once you are enrolled in the study, you will receive treatment, evaluations and follow up&#xD;
      care for your type of cancer as determined by your treating physician according to clinical&#xD;
      judgment and standard of care for your clinic. All treatments that you receive will be&#xD;
      recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment&#xD;
      outcomes, like how you respond to treatment, side effects, and progression of your cancer&#xD;
      will be collected as the information becomes available. A study coordinator or research nurse&#xD;
      at your clinic will perform a chart review annually to update your status in the database.&#xD;
      The study doctor will request any new data within the past year from you or your doctor.&#xD;
&#xD;
      We will be collecting the following data for the Registry:&#xD;
&#xD;
      At Screening: The following data will be collected from the time of diagnosis and initial&#xD;
      staging:&#xD;
&#xD;
        -  Patient demographics, date of birth, gender, race, zip code and insurance status&#xD;
&#xD;
        -  Date of diagnosis&#xD;
&#xD;
        -  Histologic or clinical diagnosis and staging relevant to diagnosis&#xD;
&#xD;
        -  Imaging studies obtained and tumor measurements&#xD;
&#xD;
        -  Lab evaluations which include routine blood tests, hormone levels, and any relevant lab&#xD;
           results needed to assess you and baseline and follow-up visits&#xD;
&#xD;
        -  Referring physician contact information&#xD;
&#xD;
      Treatment Data Collection: The following data regarding treatment will be collected:&#xD;
&#xD;
        -  Treatments received before radiation therapy, including surgery, chemotherapy, dates and&#xD;
           numbers of cycles, results of chemotherapy if available&#xD;
&#xD;
        -  Dates and doses of radiation treatment&#xD;
&#xD;
        -  Side effects observed&#xD;
&#xD;
        -  Any treatments you received at the same time as proton radiation therapy&#xD;
&#xD;
      Follow-up Data Collection: The following data will be collected either as it comes in or&#xD;
      annually following completion of your radiation therapy treatment:&#xD;
&#xD;
        -  Disease and survival status&#xD;
&#xD;
        -  Hospitalization, surgeries or other procedures&#xD;
&#xD;
        -  New diagnoses of medical conditions&#xD;
&#xD;
        -  Any lab results, including x-rays&#xD;
&#xD;
        -  Medications you are taking&#xD;
&#xD;
        -  Late side effects such as hearing loss, hormonal issues, any cardiac issues&#xD;
&#xD;
        -  Development of any new types of cancers&#xD;
&#xD;
        -  Dates of treatment after radiation therapy&#xD;
&#xD;
        -  If you discontinued radiation therapy&#xD;
&#xD;
        -  Laboratory/physician/dental or psychological evaluations&#xD;
&#xD;
        -  Use of special services in school (IEP, FM hearing system, one on one tutor, special&#xD;
           education) We would like to keep track of your medical condition for the rest of your&#xD;
           life. We would like to do this by contacting you or your doctor once a year to see how&#xD;
           you are doing. Keeping in touch with you and checking on your condition helps determine&#xD;
           the long-term outcomes of individuals treated with proton beam radiation therapy.&#xD;
&#xD;
      In addition to research personnel at MGH, there are others that may have access to the data&#xD;
      collected. This includes:&#xD;
&#xD;
        -  Other research doctors and medical centers participating in this research, if applicable&#xD;
&#xD;
        -  Outside individuals or entities that have a need to access this information to perform&#xD;
           functions relating to the conduct of this research. For instance copies of your imaging&#xD;
           studies and treatment plan will be stored at MIMcloud. MIMcloud is a service offered&#xD;
           through MIM Software Inc, a privately held company, that provides diagnostic imaging&#xD;
           data management services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Establish Registry</measure>
    <time_frame>2 years</time_frame>
    <description>Establish a registry of pediatric patients treated with proton radiation therapy in the United States</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe patterns of care</measure>
    <time_frame>2 years</time_frame>
    <description>Describe the patterns of care for pediatric patients receiving proton radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe patterns of follow-up</measure>
    <time_frame>2 years</time_frame>
    <description>Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe acute and late effects</measure>
    <time_frame>2 years</time_frame>
    <description>Describe the acute and late effects in the children treated with proton radiotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establish a cohort of photon-treated patients</measure>
    <time_frame>2 years</time_frame>
    <description>Establish a control group of patients treated with photon radiotherapy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Pediatric Patients Treated With Radiation Therapy</condition>
  <arm_group>
    <arm_group_label>Pediatric Patients Treated with Protons</arm_group_label>
    <description>Proton Radiation Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Pediatric Patients Treated with Protons</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients age &lt;22 treated with radiation therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
          1. Patients treated with radiation therapy at one of the participating centers&#xD;
&#xD;
          2. Age &lt; 22 at time of treatment start.&#xD;
&#xD;
          3. Patients may be enrolled regardless of previous local or systemic treatments received&#xD;
             prior to enrollment in the PPCR.&#xD;
&#xD;
          4. Patients may be enrolled regardless of other current local or systemic treatments or&#xD;
             disease extent.&#xD;
&#xD;
          5. Patients may be enrolled on the PPCR concurrently with another study or clinical&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torunn I Yock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Torunn I Yock, MD</last_name>
    <phone>6177266876</phone>
    <email>tyock@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida Health Proton Therapy Institute</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jackie Causer</last_name>
      <email>JCauser@floridaproton.org</email>
    </contact>
    <investigator>
      <last_name>Daniel Indelicato, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Chicago Proton Center</name>
      <address>
        <city>Warrenville</city>
        <state>Illinois</state>
        <zip>60555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Brown</last_name>
      <phone>630-821-6400</phone>
      <email>Karen.Brown@nm.org</email>
    </contact>
    <investigator>
      <last_name>William Hartsell, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maryland Proton Treatment Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jill Harper</last_name>
      <email>jillharper@umm.edu</email>
    </contact>
    <investigator>
      <last_name>Young Kwok, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Torunn I Yock, MD</last_name>
      <phone>617-726-6876</phone>
      <email>tyock@partners.org</email>
    </contact>
    <investigator>
      <last_name>Torunn I Yock, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia Laack, MD</last_name>
      <email>Laack.nadia@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Nadia Laack, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Perkins, M.D.</last_name>
      <email>sperkins@radonc.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Stephanie Perkins, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProCure Proton Therapy Center- New Jersey</name>
      <address>
        <city>Somerset</city>
        <state>New Jersey</state>
        <zip>08873</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josephine Blume</last_name>
      <email>Josephine.blume@nj.procure.com</email>
    </contact>
    <investigator>
      <last_name>Suzanne Wolden, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Proton Therapy Center</name>
      <address>
        <city>Liberty Township</city>
        <state>Ohio</state>
        <zip>45044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Fossett</last_name>
      <email>Laura.Fossett@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>John Perentesis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProCure Proton Therapy Center- Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73142</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Confer, MD</last_name>
      <email>mconfer@rma-ok.com</email>
    </contact>
    <investigator>
      <last_name>Michael Confer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania - Roberts Proton Therapy Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Hill-Kayser, M.D.</last_name>
      <email>hill@uphs.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Christine Hill-Kayser, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Provision CARES Proton Therapy Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Freeman</last_name>
      <email>natalie.freeman@biomed-research.com</email>
    </contact>
    <investigator>
      <last_name>J. Ben Wilkinson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy Philip</last_name>
      <email>nkumbalasseriyil@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Arnold Paulino, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Center for Proton Therapy</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor Mangona, MD</last_name>
      <email>Victor.Mangona@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>Victor Mangona, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington- Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Latha Parvathaneni</last_name>
      <email>lathap@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Ralph Ermoian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Torunn Yock, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Proton Therapy</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Radiation Oncology</keyword>
  <keyword>Photon Therapy</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/NCT01696721
org study id: 12-103
nct id: NCT01696721
lead sponsor: 
has dmc: No
In previous studies, Proton Beam Radiation Therapy (PBRT) has been found to show better
      results in treating patients with cancer, both because there is better control of where in
      the body the radiation is directed and because it is associated with less severe long term
      side effects. However, there is limited published data demonstrating these results. The goal
      of the Proton and Photon Consortium Registry (PPCR) is to enroll children treated with
      radiation in order to describe the population that currently receives radiation and better
      compare the short-term and long-term benefits of different types of radiotherapy. The data
      collected from this study will help facilitate research on radiation therapy and allow for
      collaborative research. The PPCR will collect demographic and clinical data that many centers
      that deliver radiation therapy already collect in routine operations.
Once you are enrolled in the study, you will receive treatment, evaluations and follow up
      care for your type of cancer as determined by your treating physician according to clinical
      judgment and standard of care for your clinic. All treatments that you receive will be
      recorded, including all surgeries and chemotherapy given before or after PBRT. Treatment
      outcomes, like how you respond to treatment, side effects, and progression of your cancer
      will be collected as the information becomes available. A study coordinator or research nurse
      at your clinic will perform a chart review annually to update your status in the database.
      The study doctor will request any new data within the past year from you or your doctor.

      We will be collecting the following data for the Registry:

      At Screening: The following data will be collected from the time of diagnosis and initial
      staging:

        -  Patient demographics, date of birth, gender, race, zip code and insurance status

        -  Date of diagnosis

        -  Histologic or clinical diagnosis and staging relevant to diagnosis

        -  Imaging studies obtained and tumor measurements

        -  Lab evaluations which include routine blood tests, hormone levels, and any relevant lab
           results needed to assess you and baseline and follow-up visits

        -  Referring physician contact information

      Treatment Data Collection: The following data regarding treatment will be collected:

        -  Treatments received before radiation therapy, including surgery, chemotherapy, dates and
           numbers of cycles, results of chemotherapy if available

        -  Dates and doses of radiation treatment

        -  Side effects observed

        -  Any treatments you received at the same time as proton radiation therapy

      Follow-up Data Collection: The following data will be collected either as it comes in or
      annually following completion of your radiation therapy treatment:

        -  Disease and survival status

        -  Hospitalization, surgeries or other procedures

        -  New diagnoses of medical conditions

        -  Any lab results, including x-rays

        -  Medications you are taking

        -  Late side effects such as hearing loss, hormonal issues, any cardiac issues

        -  Development of any new types of cancers

        -  Dates of treatment after radiation therapy

        -  If you discontinued radiation therapy

        -  Laboratory/physician/dental or psychological evaluations

        -  Use of special services in school (IEP, FM hearing system, one on one tutor, special
           education) We would like to keep track of your medical condition for the rest of your
           life. We would like to do this by contacting you or your doctor once a year to see how
           you are doing. Keeping in touch with you and checking on your condition helps determine
           the long-term outcomes of individuals treated with proton beam radiation therapy.

      In addition to research personnel at MGH, there are others that may have access to the data
      collected. This includes:

        -  Other research doctors and medical centers participating in this research, if applicable

        -  Outside individuals or entities that have a need to access this information to perform
           functions relating to the conduct of this research. For instance copies of your imaging
           studies and treatment plan will be stored at MIMcloud. MIMcloud is a service offered
           through MIM Software Inc, a privately held company, that provides diagnostic imaging
           data management services.
observational model: Cohort
time perspective: Prospective
measure: Establish Registry
time frame: 2 years
description: Establish a registry of pediatric patients treated with proton radiation therapy in the United States
measure: Describe patterns of care
time frame: 2 years
description: Describe the patterns of care for pediatric patients receiving proton radiation therapy
measure: Describe patterns of follow-up
time frame: 2 years
description: Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
measure: Describe acute and late effects
time frame: 2 years
description: Describe the acute and late effects in the children treated with proton radiotherapy
measure: Establish a cohort of photon-treated patients
time frame: 2 years
description: Establish a control group of patients treated with photon radiotherapy
arm group label: Pediatric Patients Treated with Protons
description: Proton Radiation Therapy
intervention type: Other
intervention name: No intervention
arm group label: Pediatric Patients Treated with Protons
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Torunn I Yock, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Torunn I Yock, MD
phone: 6177266876
email: tyock@partners.org
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Torunn Yock, MD
investigator title: Principal Investigator