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Radiation Medicine Patient Registry, Loma Linda University Medical Center

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ClinicalTrials.gov Identifier: NCT02436941
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2015
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jerry D. Slater, MD, 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.


Condition or disease Intervention/treatment
Cancer Radiation: Proton or Photon

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]
Estimated Enrollment : 75000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 99 Years
Official Title: Loma Linda University Medical Center Department of Radiation Medicine Patient Registry
Study Start Date : October 2003
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : October 2040



Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: One year ]
    Participants will be followed per protocol pre- during- and following treatment per protocol schedule


Secondary Outcome Measures :
  1. Local recurrence [ Time Frame: One year ]
    Participants will be followed per protocol pre- during- and following treatment per protocol schedule


Other Outcome Measures:
  1. Number of patients with adverse events [ Time Frame: One year ]
    Participants will be followed per protocol pre- during- and following treatment per protocol schedule

  2. 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



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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patients who have proton or conventional x-ray therapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02436941


Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Jerry D Slater, MD Loma Linda University

Publications:
Slater JM, Slater JD, Wroe A. Proton radiation therapy in the hospital environment: conception, development, and operation of the initial hospital-based facility, Review of Accelerator Science and Technology, Vol 2 (2009), 35-62
Slater JD. Twenty years of proton radiation therapy at Loma Linda University Medical Center. In U. Linz, editor. Ion beam therapy: fundamentals, technology, clinical applications. Berlin: Springer, 2012:581-595.

Responsible Party: Jerry D. Slater, MD, Chairman & Professor, Department of Radiation Medicine, Loma Linda University
ClinicalTrials.gov Identifier: NCT02436941     History of Changes
Other Study ID Numbers: 53191
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018