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

Recruiting

• Conditions: Cancer
• Interventions: Other: Registry

• Registration Number: NCT02070328
• Lead Sponsor: Center for Biomedical Research, LLC

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2050-01
• Study Completion: 2050-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation therapy Registry	Registry	Cancer patients who have received proton therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Ackerman Cancer Center; 🇺🇸 Jacksonville, Florida, United States

Texas Center for Proton Therapy; 🇺🇸 Irving, Texas, United States

Provision CARES Proton Therapy Nashville; 🇺🇸 Franklin, Tennessee, United States