Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The objective of this research protocol is the development of a national Proton Therapy
Center Registry for the purpose of:
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Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
-
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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radiation therapy Registry Cancer patients who have received proton therapy |
Other: Registry
|
Outcome Measures
Primary Outcome Measures
- Long-term follow-up [6 months]
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.
Secondary Outcome Measures
- Future Research Possibilities [12 months]
Performing retrospective research studies on diseases treated with proton therapy throughout the United States. 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ackerman Cancer Center | Jacksonville | Florida | United States | 32223 |
| 2 | Provision CARES Proton Therapy Nashville | Franklin | Tennessee | United States | 37067 |
| 3 | Provision Center for Proton Therapy | Knoxville | Tennessee | United States | 37909 |
| 4 | Texas Center for Proton Therapy | Irving | Texas | United States | 75063 |
Sponsors and Collaborators
- Center for Biomedical Research, LLC
- Provision Center for Proton Therapy
Investigators
- Principal Investigator: Allen Meek, M.D., Provision Center for Proton Therapy
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PRO 0425