Registro del consorcio de protones y fotones (PPCR): un registro multicéntrico de pacientes pediátricos tratados con radioterapia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Torunn I Yock, MD
- Número de teléfono: 6177266876
- Correo electrónico: tyock@partners.org
Ubicaciones de estudio
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South Australia
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Adelaide, South Australia, Australia, 5000
- Reclutamiento
- Royal Adelaide Hospital
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Contacto:
- Hien Le, A/Prof
- Correo electrónico: Hien.Le@sa.gov.au
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Investigador principal:
- Hien Le, A/Prof
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Ontario
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Toronto, Ontario, Canadá, M5G 2C1
- Reclutamiento
- University Health Network - Princess Margaret Hospital
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Contacto:
- Derek Tsang, MD
- Correo electrónico: derek.tsang@uhn.ca
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Investigador principal:
- Derek Tsang, MD
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California
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Palo Alto, California, Estados Unidos, 94304
- Reclutamiento
- Stanford University
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Contacto:
- Susan Hiniker, MD
- Correo electrónico: shiniker@stanford.edu
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Investigador principal:
- Susan Hiniker, MD
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San Diego, California, Estados Unidos, 92121
- Reclutamiento
- California Protons Cancer Therapy Center
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Investigador principal:
- Iain MacEwan, MD
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Contacto:
- Iain MacEwan, MD
- Correo electrónico: iain.macewan@californiaprotons.com
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San Francisco, California, Estados Unidos, 94143
- Reclutamiento
- University of California San Francisco
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Investigador principal:
- Steve Braunstein, MD
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Contacto:
- Steve Braunstein, MD
- Correo electrónico: Steve.Braunstein@ucsf.edu
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Florida
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Jacksonville, Florida, Estados Unidos, 32206
- Reclutamiento
- University of Florida Health Proton Therapy Institute
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Contacto:
- Daniel Indelicato, MD
- Correo electrónico: dindelicato@floridaproton.org
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Investigador principal:
- Daniel Indelicato, MD
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Reclutamiento
- Emory University
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Contacto:
- Bree Eaton, MD
- Correo electrónico: brupper@emory.edu
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Investigador principal:
- Bree Eaton, MD
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Illinois
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Warrenville, Illinois, Estados Unidos, 60555
- Reclutamiento
- Northwestern Medicine Chicago Proton Center
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Investigador principal:
- Stephen Mihalcik, MD
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Contacto:
- Stephen Mihalcik, MD
- Correo electrónico: stephen.mihalcik@nm.org
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Reclutamiento
- Maryland Proton Treatment Center
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Investigador principal:
- Young Kwok, MD
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Contacto:
- Young Kwok, MD
- Correo electrónico: ykwok@umm.edu
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Massachusetts General Hospital
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Contacto:
- Torunn I Yock, MD
- Número de teléfono: 6177266876
- Correo electrónico: tyock@partners.org
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Investigador principal:
- Torunn I Yock, MD
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic
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Contacto:
- Nadia Laack, MD
- Correo electrónico: Laack.nadia@mayo.edu
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Investigador principal:
- Nadia Laack, MD
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Reclutamiento
- Washington University
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Investigador principal:
- Stephanie Perkins, MD
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Contacto:
- Stephanie Perkins, MD
- Correo electrónico: sperkins@wustl.edu
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New Jersey
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Somerset, New Jersey, Estados Unidos, 08873
- Reclutamiento
- ProCure Proton Therapy Center- New Jersey
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Contacto:
- Josephine Blume
- Correo electrónico: Josephine.blume@nj.procure.com
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Investigador principal:
- Suzanne Wolden, MD
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New York
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New York, New York, Estados Unidos, 10035
- Reclutamiento
- New York Proton Center
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Investigador principal:
- Suzanne Wolden, MD
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Contacto:
- Suzanne Wolden, MD
- Correo electrónico: woldens@MSKCC.ORG
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Syracuse, New York, Estados Unidos, 13210
- Reclutamiento
- State University of New York Upstate Medical Center
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Contacto:
- Paul Aridgides, MD
- Correo electrónico: AridgidP@upstate.edu
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Investigador principal:
- Paul Aridgides, MD
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- Reclutamiento
- University of North Carolina
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Investigador principal:
- Dana Casey, MD
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Contacto:
- Dana Casey, MD
- Correo electrónico: dana_casey@med.unc.edu
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- The Ohio State University
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Investigador principal:
- Joshua Palmer, MD
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Contacto:
- Joshua Palmer, MD
- Correo electrónico: Joshua.Palmer@osumc.edu
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Liberty Township, Ohio, Estados Unidos, 45044
- Reclutamiento
- Cincinnati Children's Proton Therapy Center
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Investigador principal:
- John Perentesis, MD
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Contacto:
- John Perentesis, MD
- Correo electrónico: John.Perentesis@cchmc.org
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73142
- Reclutamiento
- Oklahoma Proton Center
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Contacto:
- John H Chang, MD
- Correo electrónico: John.Chang@OKCProton.com
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Investigador principal:
- John H Chang, MD
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Oklahoma City, Oklahoma, Estados Unidos, 73142
- Reclutamiento
- ProCure Proton Therapy Center- Oklahoma
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Contacto:
- Jae Y Lee, MD, PhD
- Correo electrónico: Jae.lee@procure.com
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Investigador principal:
- Jae Y Lee, MD, PhD
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- University of Pennsylvania - Roberts Proton Therapy Center
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Contacto:
- Christine Hill-Kayser, MD
- Correo electrónico: hill@uphs.upenn.edu
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Investigador principal:
- Christine Hill-Kayser, MD
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37909
- Activo, no reclutando
- Provision Center for Proton Therapy
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- MD Anderson Cancer Center
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Investigador principal:
- Arnold Paulino, MD
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Contacto:
- Arnold Paulino, MD
- Correo electrónico: APaulino@mdanderson.org
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Irving, Texas, Estados Unidos, 75063
- Reclutamiento
- Texas Center for Proton Therapy
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Contacto:
- Victor Mangona, MD
- Correo electrónico: Victor.Mangona@usoncology.com
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Investigador principal:
- Victor Mangona, MD
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Reclutamiento
- University of Utah
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Investigador principal:
- Matthew Poppe, MD
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Contacto:
- Matthew Poppe, MD
- Correo electrónico: Matthew.Poppe@hci.utah.edu
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Reclutamiento
- University of Washington- Seattle Cancer Care Alliance
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Investigador principal:
- Ralph Ermoian, MD
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Contacto:
- Ralph Ermoian, MD
- Correo electrónico: ralphpe@uw.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Pediatric patients age <22 treated with radiation therapy
Descripción
Eligibility Criteria:
- Patients treated with radiation therapy at one of the participating centers
- Age < 22 at time of treatment start.
- Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the PPCR.
- Patients may be enrolled regardless of other current local or systemic treatments or disease extent.
- Patients may be enrolled on the PPCR concurrently with another study or clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Pediatric Patients Treated with Protons
Proton Radiation Therapy |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Establish Registry
Periodo de tiempo: 2 years
|
Establish a registry of pediatric patients treated with proton radiation therapy in the United States |
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Describe patterns of care
Periodo de tiempo: 2 years
|
Describe the patterns of care for pediatric patients receiving proton radiation therapy |
2 years
|
|
Describe patterns of follow-up
Periodo de tiempo: 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 |
2 years
|
|
Describe acute and late effects
Periodo de tiempo: 2 years
|
Describe the acute and late effects in the children treated with proton radiotherapy |
2 years
|
|
Establish a cohort of photon-treated patients
Periodo de tiempo: 2 years
|
Establish a control group of patients treated with photon radiotherapy |
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Torunn I Yock, MD, Massachusetts General Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 12-103
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .