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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Registry

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Kristi Simcox, BS, CCRP; Phone Number: (865) 934-2672; Email: kristi.simcox@biomed-research.com
• Study Contact Backup: Name: James R Gray, M.D.; Phone Number: (865) 934-2672; Email: james.gray@provisionproton.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32223
      • Recruiting
      • Ackerman Cancer Center
      • Contact: Michele Katz, CRC; Phone Number: 904-880-5522; Email: michelek@ackermancancer.com
      • Contact: Cate Bernatt, CRA; Phone Number: 904-880-5522; Email: cateb@ackermancancer.com
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Recruiting
      • Provision CARES Proton Therapy Nashville
      • Contact: Kristi Simcox, BS, CCRP; Phone Number: 865-934-2672; Email: kristi.simcox@biomed-research.com
  • Texas
    • Irving, Texas, United States, 75063
      • Recruiting
      • Texas Center for Proton Therapy
      • Contact: Vanetta G. Zollicoffer, CCRC; Phone Number: 469-513-5531; Email: Vanetta.Zollicoffer@usoncology.com
      • Principal Investigator: Andrew K. Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are seen/treated at proton therapy centers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radiation therapy Registry; Cancer patients who have received proton therapy	Other: Registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Center for Biomedical Research, LLC
• Collaborators: Provision Center for Proton Therapy
• Investigators: Principal Investigator: James R Gray, M.D., Provision Center for Proton Therapy

Publications and helpful links

Helpful Links

• Provision Center for Proton Therapy

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2050
• Study Completion (ANTICIPATED): January 1, 2050

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (ESTIMATE): February 25, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Registry; Proton Therapy
• Other Study ID Numbers: PRO 0425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No