Proton and Photon Consortium Registry (PPCR): Ein multizentrisches Register von pädiatrischen Patienten, die mit Strahlentherapie behandelt wurden
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Torunn I Yock, MD
- Telefonnummer: 6177266876
- E-Mail: tyock@partners.org
Studienorte
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekrutierung
- Royal Adelaide Hospital
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Kontakt:
- Hien Le, A/Prof
- E-Mail: Hien.Le@sa.gov.au
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Hauptermittler:
- Hien Le, A/Prof
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Ontario
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Toronto, Ontario, Kanada, M5G 2C1
- Rekrutierung
- University Health Network - Princess Margaret Hospital
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Kontakt:
- Derek Tsang, MD
- E-Mail: derek.tsang@uhn.ca
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Hauptermittler:
- Derek Tsang, MD
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California
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Palo Alto, California, Vereinigte Staaten, 94304
- Rekrutierung
- Stanford University
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Kontakt:
- Susan Hiniker, MD
- E-Mail: shiniker@stanford.edu
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Hauptermittler:
- Susan Hiniker, MD
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San Diego, California, Vereinigte Staaten, 92121
- Rekrutierung
- California Protons Cancer Therapy Center
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Hauptermittler:
- Iain MacEwan, MD
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Kontakt:
- Iain MacEwan, MD
- E-Mail: iain.macewan@californiaprotons.com
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San Francisco, California, Vereinigte Staaten, 94143
- Rekrutierung
- University of California San Francisco
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Hauptermittler:
- Steve Braunstein, MD
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Kontakt:
- Steve Braunstein, MD
- E-Mail: Steve.Braunstein@ucsf.edu
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32206
- Rekrutierung
- University of Florida Health Proton Therapy Institute
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Kontakt:
- Daniel Indelicato, MD
- E-Mail: dindelicato@floridaproton.org
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Hauptermittler:
- Daniel Indelicato, MD
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308
- Rekrutierung
- Emory University
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Kontakt:
- Bree Eaton, MD
- E-Mail: brupper@emory.edu
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Hauptermittler:
- Bree Eaton, MD
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Illinois
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Warrenville, Illinois, Vereinigte Staaten, 60555
- Rekrutierung
- Northwestern Medicine Chicago Proton Center
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Hauptermittler:
- Stephen Mihalcik, MD
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Kontakt:
- Stephen Mihalcik, MD
- E-Mail: stephen.mihalcik@nm.org
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- Rekrutierung
- Maryland Proton Treatment Center
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Hauptermittler:
- Young Kwok, MD
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Kontakt:
- Young Kwok, MD
- E-Mail: ykwok@umm.edu
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Rekrutierung
- Massachusetts General Hospital
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Kontakt:
- Torunn I Yock, MD
- Telefonnummer: 6177266876
- E-Mail: tyock@partners.org
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Hauptermittler:
- Torunn I Yock, MD
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Rekrutierung
- Mayo Clinic
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Kontakt:
- Nadia Laack, MD
- E-Mail: Laack.nadia@mayo.edu
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Hauptermittler:
- Nadia Laack, MD
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Rekrutierung
- Washington University
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Hauptermittler:
- Stephanie Perkins, MD
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Kontakt:
- Stephanie Perkins, MD
- E-Mail: sperkins@wustl.edu
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New Jersey
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Somerset, New Jersey, Vereinigte Staaten, 08873
- Rekrutierung
- ProCure Proton Therapy Center- New Jersey
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Kontakt:
- Josephine Blume
- E-Mail: Josephine.blume@nj.procure.com
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Hauptermittler:
- Suzanne Wolden, MD
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New York
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New York, New York, Vereinigte Staaten, 10035
- Rekrutierung
- New York Proton Center
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Hauptermittler:
- Suzanne Wolden, MD
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Kontakt:
- Suzanne Wolden, MD
- E-Mail: woldens@MSKCC.ORG
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Syracuse, New York, Vereinigte Staaten, 13210
- Rekrutierung
- State University of New York Upstate Medical Center
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Kontakt:
- Paul Aridgides, MD
- E-Mail: AridgidP@upstate.edu
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Hauptermittler:
- Paul Aridgides, MD
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- Rekrutierung
- University of North Carolina
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Hauptermittler:
- Dana Casey, MD
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Kontakt:
- Dana Casey, MD
- E-Mail: dana_casey@med.unc.edu
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43210
- Rekrutierung
- The Ohio State University
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Hauptermittler:
- Joshua Palmer, MD
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Kontakt:
- Joshua Palmer, MD
- E-Mail: Joshua.Palmer@osumc.edu
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Liberty Township, Ohio, Vereinigte Staaten, 45044
- Rekrutierung
- Cincinnati Children's Proton Therapy Center
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Hauptermittler:
- John Perentesis, MD
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Kontakt:
- John Perentesis, MD
- E-Mail: John.Perentesis@cchmc.org
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73142
- Rekrutierung
- Oklahoma Proton Center
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Kontakt:
- John H Chang, MD
- E-Mail: John.Chang@OKCProton.com
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Hauptermittler:
- John H Chang, MD
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73142
- Rekrutierung
- ProCure Proton Therapy Center- Oklahoma
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Kontakt:
- Jae Y Lee, MD, PhD
- E-Mail: Jae.lee@procure.com
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Hauptermittler:
- Jae Y Lee, MD, PhD
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Rekrutierung
- University of Pennsylvania - Roberts Proton Therapy Center
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Kontakt:
- Christine Hill-Kayser, MD
- E-Mail: hill@uphs.upenn.edu
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Hauptermittler:
- Christine Hill-Kayser, MD
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37909
- Aktiv, nicht rekrutierend
- Provision Center for Proton Therapy
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Rekrutierung
- MD Anderson Cancer Center
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Hauptermittler:
- Arnold Paulino, MD
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Kontakt:
- Arnold Paulino, MD
- E-Mail: APaulino@mdanderson.org
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Irving, Texas, Vereinigte Staaten, 75063
- Rekrutierung
- Texas Center for Proton Therapy
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Kontakt:
- Victor Mangona, MD
- E-Mail: Victor.Mangona@usoncology.com
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Hauptermittler:
- Victor Mangona, MD
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Utah
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Salt Lake City, Utah, Vereinigte Staaten, 84112
- Rekrutierung
- University of Utah
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Hauptermittler:
- Matthew Poppe, MD
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Kontakt:
- Matthew Poppe, MD
- E-Mail: Matthew.Poppe@hci.utah.edu
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Washington
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Seattle, Washington, Vereinigte Staaten, 98109
- Rekrutierung
- University of Washington- Seattle Cancer Care Alliance
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Hauptermittler:
- Ralph Ermoian, MD
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Kontakt:
- Ralph Ermoian, MD
- E-Mail: ralphpe@uw.edu
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Pediatric patients age <22 treated with radiation therapy
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Pediatric Patients Treated with Protons
Proton Radiation Therapy |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Establish Registry
Zeitfenster: 2 years
|
Establish a registry of pediatric patients treated with proton radiation therapy in the United States |
2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Describe patterns of care
Zeitfenster: 2 years
|
Describe the patterns of care for pediatric patients receiving proton radiation therapy |
2 years
|
|
Describe patterns of follow-up
Zeitfenster: 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
Zeitfenster: 2 years
|
Describe the acute and late effects in the children treated with proton radiotherapy |
2 years
|
|
Establish a cohort of photon-treated patients
Zeitfenster: 2 years
|
Establish a control group of patients treated with photon radiotherapy |
2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Torunn I Yock, MD, Massachusetts General Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Geschätzt)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 12-103
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