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Trial record 1 of 1 for:    nct01696721
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Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy

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ClinicalTrials.gov Identifier: NCT01696721
Recruitment Status : Recruiting
First Posted : October 1, 2012
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date September 27, 2012
First Posted Date October 1, 2012
Last Update Posted Date December 6, 2019
Study Start Date July 2012
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2012)
Establish Registry [ Time Frame: 2 years ]
Establish a registry of pediatric patients treated with proton radiation therapy in the United States
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2019)
  • Describe patterns of care [ Time Frame: 2 years ]
    Describe the patterns of care for pediatric patients receiving proton radiation therapy
  • Describe patterns of follow-up [ Time Frame: 2 years ]
    Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
  • Describe acute and late effects [ Time Frame: 2 years ]
    Describe the acute and late effects in the children treated with proton radiotherapy
  • Establish a cohort of photon-treated patients [ Time Frame: 2 years ]
    Establish a control group of patients treated with photon radiotherapy
Original Secondary Outcome Measures
 (submitted: September 27, 2012)
  • Describe patterns of care [ Time Frame: 2 years ]
    Describe the patterns of care for pediatric patients receiving proton radiation therapy
  • Describe patterns of follow-up [ Time Frame: 2 years ]
    Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
  • Describe acute and late effects [ Time Frame: 2 years ]
    Describe the acute and late effects in the children treated with proton radiotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
Official Title Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
Brief Summary 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.
Detailed Description

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric patients age <22 treated with radiation therapy
Condition Pediatric Patients Treated With Radiation Therapy
Intervention Other: No intervention
Study Groups/Cohorts Pediatric Patients Treated with Protons
Proton Radiation Therapy
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 11, 2014)
5000
Original Estimated Enrollment
 (submitted: September 27, 2012)
1500
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Eligibility Criteria:

  1. Patients treated with radiation therapy at one of the participating centers
  2. Age < 22 at time of treatment start.
  3. Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
  4. Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
  5. Patients may be enrolled on the PPCR concurrently with another study or clinical trial.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Torunn I Yock, MD 6177266876 tyock@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01696721
Other Study ID Numbers 12-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Torunn Yock, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2019