Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-14 @ 1:17 AM
Study NCT ID:
NCT02070328
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Sponsor:
Center for Biomedical Research, LLC
Organization:
Study Overview
Official Title:
Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: