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

Cancer Clinical Trial

— Registry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02070328
• Other study ID #: PRO 0425
• Status: Recruiting
• Start date: December 2013
• Est. completion date: January 2050

Study information

• Verified date: February 2023
• Source: Center for Biomedical Research, LLC
• Contact: Kristi Simcox, BS, CCRP
• Phone: (865) 934-2672
• Email: kristi.simcox[@]biomed-research.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2050
• Est. primary completion date: January 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Registry

Locations

Country	Name	City	State
United States	Provision CARES Proton Therapy Nashville	Franklin	Tennessee
United States	Texas Center for Proton Therapy	Irving	Texas
United States	Ackerman Cancer Center	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Center for Biomedical Research, LLC	Provision Center for Proton Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term follow-up	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.	6 months
Secondary	Future Research Possibilities	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.	12 months

External Links

•   Provision Center for Proton Therapy