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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01696721
Registration number
NCT01696721
Ethics application status
Date submitted
27/09/2012
Date registered
1/10/2012
Date last updated
15/08/2025
Titles & IDs
Public title
Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
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Scientific title
Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy
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Secondary ID [1]
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12-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pediatric Patients Treated With Radiation Therapy
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Pediatric Patients Treated with Protons - Proton Radiation Therapy
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Establish Registry
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Assessment method [1]
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Establish a registry of pediatric patients treated with proton radiation therapy in the United States
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Describe patterns of care
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Assessment method [1]
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Describe the patterns of care for pediatric patients receiving proton radiation therapy
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Describe patterns of follow-up
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Assessment method [2]
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Describe the patterns of follow-up at proton facilities where patients are often referred from a significant distance and from centers of excellence
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Describe acute and late effects
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Assessment method [3]
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Describe the acute and late effects in the children treated with proton radiotherapy
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Establish a cohort of photon-treated patients
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Assessment method [4]
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Establish a control group of patients treated with photon radiotherapy
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Timepoint [4]
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2 years
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Eligibility
Key inclusion 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.
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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State/province [18]
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Washington
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Country [19]
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Canada
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State/province [19]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
Massachusetts General Hospital
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01696721
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Trial related presentations / publications
Krisch JM, Ermoian RP, Indelicato DJ, Lee JY, Perentesis JP, Perkins SM, Laack NN 2nd, Chang JH, MacEwan IJ, Wolden SL, Wang D, Yock TI, Aridgides PD. Outcomes following radiation therapy for embryonal tumor with multilayered rosettes (ETMR): results from the Pediatric Proton/Photon Consortium Registry (PPCR). J Neurooncol. 2025 Sep;174(2):369-380. doi: 10.1007/s11060-025-05065-2. Epub 2025 May 13.
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Public notes
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Contacts
Principal investigator
Name
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Torunn I Yock, MD
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Address
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Massachusetts General Hospital
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Email
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Contact person for public queries
Name
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Torunn I Yock, MD
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Address
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Phone
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6177266876
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01696721
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