Proton and Photon Consortium Registry (PPCR): A Multi Center Registry of Pediatric Patients Treated With Radiation Therapy



Status:Recruiting
Healthy:No
Age Range:Any - 21
Updated:4/3/2019
Start Date:July 2012
End Date:December 2025
Contact:Torunn I Yock, MD
Email:tyock@partners.org
Phone:6177266876

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
14
sites
Saint Louis, Missouri 63110
Principal Investigator: Stephanie Perkins, M.D.
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Saint Louis, MO
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Torunn I Yock, MD
Phone: 617-726-6876
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Boston, MA
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Baltimore, Maryland 21201
Principal Investigator: Young Kwok, MD
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Baltimore, MD
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Houston, Texas 77030
Principal Investigator: Arnold Paulino, MD
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Houston, TX
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Irving, Texas 75063
Principal Investigator: Victor Mangona, MD
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Irving, TX
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Jacksonville, Florida 32206
Principal Investigator: Daniel Indelicato, M.D.
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Jacksonville, FL
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Knoxville, Tennessee 37909
Principal Investigator: J. Ben Wilkinson, MD
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Knoxville, TN
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Liberty Township, Ohio 45044
Principal Investigator: John Perentesis, MD
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Liberty Township, OH
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5901 West Memorial Road
Oklahoma City, Oklahoma 73142
Principal Investigator: Michael Confer, MD
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19104
Principal Investigator: Christine Hill-Kayser, M.D.
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Philadelphia, PA
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Rochester, Minnesota 55905
Principal Investigator: Nadia Laack, MD
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Rochester, MN
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Seattle, Washington 98109
Principal Investigator: Ralph Ermoian, MD
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Seattle, WA
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103 Cedar Grove Lane
Somerset, New Jersey 08873
Principal Investigator: Suzanne Wolden, MD
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Somerset, NJ
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Warrenville, Illinois 60555
Principal Investigator: William Hartsell, M.D.
Phone: 630-821-6400
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Warrenville, IL
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