Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Registry.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other Registry
Primary outcome measures
- Long-term follow-up [Time frame: 6 months]
Secondary outcome measures (1)
- Future Research Possibilities [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 3 centers
- Ackerman Cancer Center — Jacksonville
- Provision CARES Proton Therapy Nashville — Franklin
- Texas Center for Proton Therapy — Irving
Identifiers
NCT: NCT02070328 · PRO 0425