Proton and Photon Consortium Registry (PPCR) : registre multicentrique des patients pédiatriques traités par radiothérapie
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Torunn I Yock, MD
- Numéro de téléphone: 6177266876
- E-mail: tyock@partners.org
Lieux d'étude
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South Australia
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Adelaide, South Australia, Australie, 5000
- Recrutement
- Royal Adelaide Hospital
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Contact:
- Hien Le, A/Prof
- E-mail: Hien.Le@sa.gov.au
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Chercheur principal:
- Hien Le, A/Prof
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Ontario
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Toronto, Ontario, Canada, M5G 2C1
- Recrutement
- University Health Network - Princess Margaret Hospital
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Contact:
- Derek Tsang, MD
- E-mail: derek.tsang@uhn.ca
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Chercheur principal:
- Derek Tsang, MD
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California
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Palo Alto, California, États-Unis, 94304
- Recrutement
- Stanford University
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Contact:
- Susan Hiniker, MD
- E-mail: shiniker@stanford.edu
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Chercheur principal:
- Susan Hiniker, MD
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San Diego, California, États-Unis, 92121
- Recrutement
- California Protons Cancer Therapy Center
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Chercheur principal:
- Iain MacEwan, MD
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Contact:
- Iain MacEwan, MD
- E-mail: iain.macewan@californiaprotons.com
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San Francisco, California, États-Unis, 94143
- Recrutement
- University of California San Francisco
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Chercheur principal:
- Steve Braunstein, MD
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Contact:
- Steve Braunstein, MD
- E-mail: Steve.Braunstein@ucsf.edu
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Florida
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Jacksonville, Florida, États-Unis, 32206
- Recrutement
- University of Florida Health Proton Therapy Institute
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Contact:
- Daniel Indelicato, MD
- E-mail: dindelicato@floridaproton.org
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Chercheur principal:
- Daniel Indelicato, MD
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Recrutement
- Emory University
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Contact:
- Bree Eaton, MD
- E-mail: brupper@emory.edu
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Chercheur principal:
- Bree Eaton, MD
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Illinois
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Warrenville, Illinois, États-Unis, 60555
- Recrutement
- Northwestern Medicine Chicago Proton Center
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Chercheur principal:
- Stephen Mihalcik, MD
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Contact:
- Stephen Mihalcik, MD
- E-mail: stephen.mihalcik@nm.org
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Recrutement
- Maryland Proton Treatment Center
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Chercheur principal:
- Young Kwok, MD
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Contact:
- Young Kwok, MD
- E-mail: ykwok@umm.edu
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
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Contact:
- Torunn I Yock, MD
- Numéro de téléphone: 6177266876
- E-mail: tyock@partners.org
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Chercheur principal:
- Torunn I Yock, MD
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Recrutement
- Mayo Clinic
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Contact:
- Nadia Laack, MD
- E-mail: Laack.nadia@mayo.edu
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Chercheur principal:
- Nadia Laack, MD
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University
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Chercheur principal:
- Stephanie Perkins, MD
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Contact:
- Stephanie Perkins, MD
- E-mail: sperkins@wustl.edu
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New Jersey
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Somerset, New Jersey, États-Unis, 08873
- Recrutement
- ProCure Proton Therapy Center- New Jersey
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Contact:
- Josephine Blume
- E-mail: Josephine.blume@nj.procure.com
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Chercheur principal:
- Suzanne Wolden, MD
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New York
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New York, New York, États-Unis, 10035
- Recrutement
- New York Proton Center
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Chercheur principal:
- Suzanne Wolden, MD
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Contact:
- Suzanne Wolden, MD
- E-mail: woldens@MSKCC.ORG
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Syracuse, New York, États-Unis, 13210
- Recrutement
- State University of New York Upstate Medical Center
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Contact:
- Paul Aridgides, MD
- E-mail: AridgidP@upstate.edu
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Chercheur principal:
- Paul Aridgides, MD
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- Recrutement
- University of North Carolina
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Chercheur principal:
- Dana Casey, MD
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Contact:
- Dana Casey, MD
- E-mail: dana_casey@med.unc.edu
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Recrutement
- The Ohio State University
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Chercheur principal:
- Joshua Palmer, MD
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Contact:
- Joshua Palmer, MD
- E-mail: Joshua.Palmer@osumc.edu
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Liberty Township, Ohio, États-Unis, 45044
- Recrutement
- Cincinnati Children's Proton Therapy Center
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Chercheur principal:
- John Perentesis, MD
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Contact:
- John Perentesis, MD
- E-mail: John.Perentesis@cchmc.org
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73142
- Recrutement
- Oklahoma Proton Center
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Contact:
- John H Chang, MD
- E-mail: John.Chang@OKCProton.com
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Chercheur principal:
- John H Chang, MD
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Oklahoma City, Oklahoma, États-Unis, 73142
- Recrutement
- ProCure Proton Therapy Center- Oklahoma
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Contact:
- Jae Y Lee, MD, PhD
- E-mail: Jae.lee@procure.com
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Chercheur principal:
- Jae Y Lee, MD, PhD
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Recrutement
- University of Pennsylvania - Roberts Proton Therapy Center
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Contact:
- Christine Hill-Kayser, MD
- E-mail: hill@uphs.upenn.edu
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Chercheur principal:
- Christine Hill-Kayser, MD
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Tennessee
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Knoxville, Tennessee, États-Unis, 37909
- Actif, ne recrute pas
- Provision Center for Proton Therapy
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- MD Anderson Cancer Center
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Chercheur principal:
- Arnold Paulino, MD
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Contact:
- Arnold Paulino, MD
- E-mail: APaulino@mdanderson.org
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Irving, Texas, États-Unis, 75063
- Recrutement
- Texas Center for Proton Therapy
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Contact:
- Victor Mangona, MD
- E-mail: Victor.Mangona@usoncology.com
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Chercheur principal:
- Victor Mangona, MD
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Recrutement
- University of Utah
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Chercheur principal:
- Matthew Poppe, MD
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Contact:
- Matthew Poppe, MD
- E-mail: Matthew.Poppe@hci.utah.edu
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Washington
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Seattle, Washington, États-Unis, 98109
- Recrutement
- University of Washington- Seattle Cancer Care Alliance
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Chercheur principal:
- Ralph Ermoian, MD
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Contact:
- Ralph Ermoian, MD
- E-mail: ralphpe@uw.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Pediatric patients age <22 treated with radiation therapy
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Pediatric Patients Treated with Protons
Proton Radiation Therapy |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Establish Registry
Délai: 2 years
|
Establish a registry of pediatric patients treated with proton radiation therapy in the United States |
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Describe patterns of care
Délai: 2 years
|
Describe the patterns of care for pediatric patients receiving proton radiation therapy |
2 years
|
|
Describe patterns of follow-up
Délai: 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
Délai: 2 years
|
Describe the acute and late effects in the children treated with proton radiotherapy |
2 years
|
|
Establish a cohort of photon-treated patients
Délai: 2 years
|
Establish a control group of patients treated with photon radiotherapy |
2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Torunn I Yock, MD, Massachusetts General Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 12-103
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