Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/2/2019
Start Date:December 2013
End Date:January 2022
Contact:Natalie E Freeman, PhD
Email:natalie.freeman@biomed-research.com
Phone:8659342672

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Proton therapy is a limited medical resource that is more expensive than conventional x-ray
therapy. To correctly measure the success of proton therapy in treating different conditions,
it is important to check a patient's health status after their treatment is finished.
Checking on the progress of patients over many years (called long-term follow-up) is needed
because the long-term effects of proton therapy are not well known.

The objective of this research protocol is the development of a national Proton Therapy
Center Registry for the purpose of:

1. Performing retrospective research studies on diseases treated with proton therapy
throughout the United States.

2. Maintaining regular, lifetime contact with subjects in order to obtain current
identification , contact information, and self/parent-reported health status in order to
obtain a better understanding of overall treatment strategies and patient benefits of
treatment.

3. Permitting review of medical record information contained within the Registry to
identify subjects who may be eligible for participation in future research studies
conducted at the Proton Therapy Institution where the participant was treated. Obtaining
the permission of Research Registry participants to be contacted to ascertain their
interest in participating in future research studies being conducted at their
participating Proton Therapy Institution for which it appears (i.e., based on medical
information contained within the Research Registry) they may be eligible.

Inclusion Criteria:

- All subjects who are receiving or seeking medical care at the participating Proton
Therapy Center will be invited to participate in the Research Registry.

Exclusion Criteria:

- Subjects who do not agree to participate
We found this trial at
4
sites
Irving, Texas 75063
Principal Investigator: Andrew K. Lee, MD
Phone: 469-513-5500
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Franklin, Tennessee 37067
Principal Investigator: James Gray, MD
Phone: 865-934-2672
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Franklin, TN
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Jacksonville, Florida 32223
Phone: 904-880-5522
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Jacksonville, FL
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Knoxville, Tennessee 37909
Principal Investigator: J. Ben Wilkinson, MD
Phone: 865-934-2670
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Knoxville, TN
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