Radiation Medicine Patient Registry, Loma Linda University Medical Center

• Conditions: Cancer

• Registration Number: NCT02436941
• Lead Sponsor: Loma Linda University

Brief Summary

For most cancers, long-term follow-up is the best measure of treatment effectiveness. The Department of Radiation Medicine at Loma Linda University Medical Center operates the James M. Slater, M.D., Proton Treatment and Research Center, the world's first hospital-based proton treatment facility. Patients have been treated at the Center since 1990. Radiation treatment has been expanded and refined since the Center's opening, and these changes have been based primarily on outcomes seen and evaluated in long-term follow-up.

The Radiation Medicine Patient Registry (a multi-year database), which began as an IRB-approved study in 2003, including detailed follow-up of study data collected from 1990 and onward, is designed to track all medical information from patients treated with proton therapy and/or conventional X-ray therapy at Loma Linda University Medical Center. Information gathered from patients treated years or even decades ago helps to determine the most effective use of proton and conventional radiation in caring for patients with cancers and other diseases.

Detailed Description

The patient registry will be posted to accomplish three objectives:

1. Perform retrospective research studies on diseases treated with proton therapy and conventional photon radiation.

2. Maintain regular and life-long contact with patients in order to obtain current identification, contact information, and self/parent-reported health status. This information is used to generate better understanding of treatment strategies and, in turn, increase benefits to patients.

3. Enable physicians to review of medical record information and so to identify subjects who may be eligible to participate in future research studies. This requires obtaining permission from registered participants that they may be contacted and asked if they are interested in participating in studies for which they may be eligible, as determined by their medical information contained in the registry.

Study Timeline

• Study Start: 2003-10-20
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2040-03
• Study Completion: 2050-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75000

Inclusion Criteria

• Diagnosis of benign or malignant tumors or other conditions deemed treatable by proton or conventional photon radiotherapy
• Willingness to sign an Informed Consent Document

Exclusion Criteria

• There are no specific exclusion criteria, but patients who are unwilling to sign the ICD will not be included

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival	One year	Participants will be followed per protocol pre- during- and following treatment per protocol schedule

Secondary Outcome Measures

Name	Time	Method
Local recurrence	One year	Participants will be followed per protocol pre- during- and following treatment per protocol schedule