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Radiation Medicine Patient Registry, Loma Linda University Medical Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436941
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2015
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Jerry D. Slater, MD, Loma Linda University

Tracking Information
First Submitted Date March 27, 2015
First Posted Date May 7, 2015
Last Update Posted Date February 20, 2020
Study Start Date October 2003
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2015)
Disease-free survival [ Time Frame: One year ]
Participants will be followed per protocol pre- during- and following treatment per protocol schedule
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 4, 2015)
Local recurrence [ Time Frame: One year ]
Participants will be followed per protocol pre- during- and following treatment per protocol schedule
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 4, 2015)
  • Number of patients with adverse events [ Time Frame: One year ]
    Participants will be followed per protocol pre- during- and following treatment per protocol schedule
  • Overall survival & Long-term follow-up [ Time Frame: One year ]
    Maintaining regular, lifetime contact with patients enables physicians to obtain current identification, contact information, and self/parent-reported health status that can, in turn, generate better understanding of treatment strategies and subsequent benefits to patients
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Radiation Medicine Patient Registry, Loma Linda University Medical Center
Official Title Loma Linda University Medical Center Department of Radiation Medicine Patient Registry
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 99 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any patients who have proton or conventional x-ray therapy
Condition Cancer
Intervention Radiation: Proton or Photon
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 4, 2015)
75000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2050
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02436941
Other Study ID Numbers 53191
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jerry D. Slater, MD, Loma Linda University
Study Sponsor Loma Linda University
Collaborators Not Provided
Investigators
Principal Investigator: Jerry D Slater, MD Loma Linda University
PRS Account Loma Linda University
Verification Date February 2020