Proton and Photon Consortium Registry (PPCR): 放射線治療を受けた小児患者の多施設登録
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Torunn I Yock, MD
- 電話番号:6177266876
- メール:tyock@partners.org
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94304
- 募集
- Stanford University
-
コンタクト:
- Susan Hiniker, MD
- メール:shiniker@stanford.edu
-
主任研究者:
- Susan Hiniker, MD
-
San Diego、California、アメリカ、92121
- 募集
- California Protons Cancer Therapy Center
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主任研究者:
- Iain MacEwan, MD
-
コンタクト:
- Iain MacEwan, MD
- メール:iain.macewan@californiaprotons.com
-
San Francisco、California、アメリカ、94143
- 募集
- University of California San Francisco
-
主任研究者:
- Steve Braunstein, MD
-
コンタクト:
- Steve Braunstein, MD
- メール:Steve.Braunstein@ucsf.edu
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-
Florida
-
Jacksonville、Florida、アメリカ、32206
- 募集
- University of Florida Health Proton Therapy Institute
-
コンタクト:
- Daniel Indelicato, MD
- メール:dindelicato@floridaproton.org
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主任研究者:
- Daniel Indelicato, MD
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30308
- 募集
- Emory University
-
コンタクト:
- Bree Eaton, MD
- メール:brupper@emory.edu
-
主任研究者:
- Bree Eaton, MD
-
-
Illinois
-
Warrenville、Illinois、アメリカ、60555
- 募集
- Northwestern Medicine Chicago Proton Center
-
主任研究者:
- Stephen Mihalcik, MD
-
コンタクト:
- Stephen Mihalcik, MD
- メール:stephen.mihalcik@nm.org
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Maryland
-
Baltimore、Maryland、アメリカ、21201
- 募集
- Maryland Proton Treatment Center
-
主任研究者:
- Young Kwok, MD
-
コンタクト:
- Young Kwok, MD
- メール:ykwok@umm.edu
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-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- 募集
- Massachusetts General Hospital
-
コンタクト:
- Torunn I Yock, MD
- 電話番号:6177266876
- メール:tyock@partners.org
-
主任研究者:
- Torunn I Yock, MD
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic
-
コンタクト:
- Nadia Laack, MD
- メール:Laack.nadia@mayo.edu
-
主任研究者:
- Nadia Laack, MD
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- 募集
- Washington University
-
主任研究者:
- Stephanie Perkins, MD
-
コンタクト:
- Stephanie Perkins, MD
- メール:sperkins@wustl.edu
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New Jersey
-
Somerset、New Jersey、アメリカ、08873
- 募集
- ProCure Proton Therapy Center- New Jersey
-
コンタクト:
- Josephine Blume
- メール:Josephine.blume@nj.procure.com
-
主任研究者:
- Suzanne Wolden, MD
-
-
New York
-
New York、New York、アメリカ、10035
- 募集
- New York Proton Center
-
主任研究者:
- Suzanne Wolden, MD
-
コンタクト:
- Suzanne Wolden, MD
- メール:woldens@MSKCC.ORG
-
Syracuse、New York、アメリカ、13210
- 募集
- State University of New York Upstate Medical Center
-
コンタクト:
- Paul Aridgides, MD
- メール:AridgidP@upstate.edu
-
主任研究者:
- Paul Aridgides, MD
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27514
- 募集
- University of North Carolina
-
主任研究者:
- Dana Casey, MD
-
コンタクト:
- Dana Casey, MD
- メール:dana_casey@med.unc.edu
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- The Ohio State University
-
主任研究者:
- Joshua Palmer, MD
-
コンタクト:
- Joshua Palmer, MD
- メール:Joshua.Palmer@osumc.edu
-
Liberty Township、Ohio、アメリカ、45044
- 募集
- Cincinnati Children's Proton Therapy Center
-
主任研究者:
- John Perentesis, MD
-
コンタクト:
- John Perentesis, MD
- メール:John.Perentesis@cchmc.org
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73142
- 募集
- Oklahoma Proton Center
-
コンタクト:
- John H Chang, MD
- メール:John.Chang@OKCProton.com
-
主任研究者:
- John H Chang, MD
-
Oklahoma City、Oklahoma、アメリカ、73142
- 募集
- ProCure Proton Therapy Center- Oklahoma
-
コンタクト:
- Jae Y Lee, MD, PhD
- メール:Jae.lee@procure.com
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主任研究者:
- Jae Y Lee, MD, PhD
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- University of Pennsylvania - Roberts Proton Therapy Center
-
コンタクト:
- Christine Hill-Kayser, MD
- メール:hill@uphs.upenn.edu
-
主任研究者:
- Christine Hill-Kayser, MD
-
-
Tennessee
-
Knoxville、Tennessee、アメリカ、37909
- 積極的、募集していない
- Provision Center for Proton Therapy
-
-
Texas
-
Houston、Texas、アメリカ、77030
- 募集
- MD Anderson Cancer Center
-
主任研究者:
- Arnold Paulino, MD
-
コンタクト:
- Arnold Paulino, MD
- メール:APaulino@mdanderson.org
-
Irving、Texas、アメリカ、75063
- 募集
- Texas Center for Proton Therapy
-
コンタクト:
- Victor Mangona, MD
- メール:Victor.Mangona@usoncology.com
-
主任研究者:
- Victor Mangona, MD
-
-
Utah
-
Salt Lake City、Utah、アメリカ、84112
- 募集
- University of Utah
-
主任研究者:
- Matthew Poppe, MD
-
コンタクト:
- Matthew Poppe, MD
- メール:Matthew.Poppe@hci.utah.edu
-
-
Washington
-
Seattle、Washington、アメリカ、98109
- 募集
- University of Washington- Seattle Cancer Care Alliance
-
主任研究者:
- Ralph Ermoian, MD
-
コンタクト:
- Ralph Ermoian, MD
- メール:ralphpe@uw.edu
-
-
-
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- 募集
- Royal Adelaide Hospital
-
コンタクト:
- Hien Le, A/Prof
- メール:Hien.Le@sa.gov.au
-
主任研究者:
- Hien Le, A/Prof
-
-
-
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Ontario
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Toronto、Ontario、カナダ、M5G 2C1
- 募集
- University Health Network - Princess Margaret Hospital
-
コンタクト:
- Derek Tsang, MD
- メール:derek.tsang@uhn.ca
-
主任研究者:
- Derek Tsang, MD
-
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Pediatric patients age <22 treated with radiation therapy
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Pediatric Patients Treated with Protons
Proton Radiation Therapy |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Establish Registry
時間枠:2 years
|
Establish a registry of pediatric patients treated with proton radiation therapy in the United States |
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Describe patterns of care
時間枠:2 years
|
Describe the patterns of care for pediatric patients receiving proton radiation therapy |
2 years
|
|
Describe patterns of follow-up
時間枠: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
時間枠:2 years
|
Describe the acute and late effects in the children treated with proton radiotherapy |
2 years
|
|
Establish a cohort of photon-treated patients
時間枠:2 years
|
Establish a control group of patients treated with photon radiotherapy |
2 years
|
協力者と研究者
捜査官
- 主任研究者:Torunn I Yock, MD、Massachusetts General Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。