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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02070328
Acronym
Registry
Enrollment
300
Registered
2014-02-25
Start date
2013-12-31
Completion date
2050-01-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Proton Therapy, Registry

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.

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

OTHERRegistry

Sponsors

Provision Center for Proton Therapy
CollaboratorOTHER
Center for Biomedical Research, LLC
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Long-term follow-up6 monthsMaintaining 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

MeasureTime frameDescription
Future Research Possibilities12 monthsPerforming 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.

Countries

United States

Contacts

Primary ContactKristi Simcox, BS, CCRP
kristi.simcox@biomed-research.com(865) 934-2672
Backup ContactJames R Gray, M.D.
james.gray@provisionproton.com(865) 934-2672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026