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

Center for Biomedical Research, LLC

Status: Enrolling

Conditions: Cancer

Treatments: Other: Registry

Study type: Observational

Funder types: Other

Identifiers

NCT02070328

PRO 0425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Radiation therapy Registry

Description:

Cancer patients who have received proton therapy

Treatment:

Other: Registry