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Proton and Photon Consortium Registry (PPCR): Et multisenterregister over pediatriske pasienter behandlet med strålebehandling

2. oktober 2026 oppdatert av: Torunn Yock, MD, Massachusetts General Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

5000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Rekruttering
        • Royal Adelaide Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hien Le, A/Prof
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C1
        • Rekruttering
        • University Health Network - Princess Margaret Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Derek Tsang, MD
  • Forente stater
    • California
      • Palo Alto, California, Forente stater, 94304
        • Rekruttering
        • Stanford University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Susan Hiniker, MD
      • San Diego, California, Forente stater, 92121
      • San Francisco, California, Forente stater, 94143
        • Rekruttering
        • University of California San Francisco
        • Hovedetterforsker:
          • Steve Braunstein, MD
        • Ta kontakt med:
    • Florida
      • Jacksonville, Florida, Forente stater, 32206
        • Rekruttering
        • University of Florida Health Proton Therapy Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniel Indelicato, MD
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • Rekruttering
        • Emory University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bree Eaton, MD
    • Illinois
      • Warrenville, Illinois, Forente stater, 60555
        • Rekruttering
        • Northwestern Medicine Chicago Proton Center
        • Hovedetterforsker:
          • Stephen Mihalcik, MD
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Rekruttering
        • Maryland Proton Treatment Center
        • Hovedetterforsker:
          • Young Kwok, MD
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Torunn I Yock, MD
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nadia Laack, MD
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University
        • Hovedetterforsker:
          • Stephanie Perkins, MD
        • Ta kontakt med:
    • New Jersey
      • Somerset, New Jersey, Forente stater, 08873
        • Rekruttering
        • ProCure Proton Therapy Center- New Jersey
        • Ta kontakt med:
        • Hovedetterforsker:
          • Suzanne Wolden, MD
    • New York
      • New York, New York, Forente stater, 10035
        • Rekruttering
        • New York Proton Center
        • Hovedetterforsker:
          • Suzanne Wolden, MD
        • Ta kontakt med:
      • Syracuse, New York, Forente stater, 13210
        • Rekruttering
        • State University of New York Upstate Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul Aridgides, MD
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27514
        • Rekruttering
        • University of North Carolina
        • Hovedetterforsker:
          • Dana Casey, MD
        • Ta kontakt med:
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • Rekruttering
        • The Ohio State University
        • Hovedetterforsker:
          • Joshua Palmer, MD
        • Ta kontakt med:
      • Liberty Township, Ohio, Forente stater, 45044
        • Rekruttering
        • Cincinnati Children's Proton Therapy Center
        • Hovedetterforsker:
          • John Perentesis, MD
        • Ta kontakt med:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73142
        • Rekruttering
        • Oklahoma Proton Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • John H Chang, MD
      • Oklahoma City, Oklahoma, Forente stater, 73142
        • Rekruttering
        • ProCure Proton Therapy Center- Oklahoma
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jae Y Lee, MD, PhD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • University of Pennsylvania - Roberts Proton Therapy Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christine Hill-Kayser, MD
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Aktiv, ikke rekrutterende
        • Provision Center for Proton Therapy
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Hovedetterforsker:
          • Arnold Paulino, MD
        • Ta kontakt med:
      • Irving, Texas, Forente stater, 75063
        • Rekruttering
        • Texas Center for Proton Therapy
        • Ta kontakt med:
        • Hovedetterforsker:
          • Victor Mangona, MD
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Rekruttering
        • University of Utah
        • Hovedetterforsker:
          • Matthew Poppe, MD
        • Ta kontakt med:
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Rekruttering
        • University of Washington- Seattle Cancer Care Alliance
        • Hovedetterforsker:
          • Ralph Ermoian, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pediatric patients age <22 treated with radiation therapy

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Pediatric Patients Treated with Protons

Proton Radiation Therapy
Annen: Ingen inngrep

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Establish Registry
Tidsramme: 2 years

Establish a registry of pediatric patients treated with proton radiation therapy in the United States
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Describe patterns of care
Tidsramme: 2 years

Describe the patterns of care for pediatric patients receiving proton radiation therapy
2 years
Describe patterns of follow-up
Tidsramme: 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
Tidsramme: 2 years

Describe the acute and late effects in the children treated with proton radiotherapy
2 years
Establish a cohort of photon-treated patients
Tidsramme: 2 years

Establish a control group of patients treated with photon radiotherapy
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Etterforskere

  • Hovedetterforsker: Torunn I Yock, MD, Massachusetts General Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2012

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

27. september 2012

Først innsendt som oppfylte QC-kriteriene

27. september 2012

Først lagt ut (Antatt)

1. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 12-103

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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