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Registry for Proton Beam Radiation Therapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040467
Recruitment Status : Recruiting
First Posted : January 20, 2014
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The goal is to collect information on each patient treated with proton beam radiation therapy.

Condition or disease
Carcinoma

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Registry for Proton Beam Radiation Therapy
Actual Study Start Date : December 18, 2013
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Treatment-specific data for all patients receiving proton beam radiation therapy [ Time Frame: 10 years ]
    Treatment-specific data collection record for all patients receiving proton beam radiation therapy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient receiving proton beam therapy
Criteria

Inclusion Criteria:

-Any patient receiving proton beam therapy is eligible for enrollment to this registry (regardless of diagnosis, age, other concurrent therapies, etc.) provided s/he consents to participate.

Contacts and Locations
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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): NCT02040467


Contacts
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Contact: Jeff Michalski, M.D. 314-362-8566 jmichalski@wustl.edu

Locations
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United States, Florida
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Naren Ramakrishna, M.D. Ph.D.    321-841-8650    Naren.Ramakrishna@orlandohealth.com   
Principal Investigator: Naren Ramakrishna, M.D., Ph.D.         
United States, Georgia
Emory University Withdrawn
Atlanta, Georgia, United States, 30308
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff Michalski, M.D.    314-362-8566    jmichalski@wustl.edu   
Principal Investigator: Jeff Michalski, M.D.         
United States, New Jersey
Rutgers University Completed
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John Perentesis, M.D.    513-636-8241    john.perentesis@cchmc.org   
Principal Investigator: John Perentesis, M.D.         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: John Breneman, M.D.    513-584-5327    brenemjc@ucmail.uc.edu   
Principal Investigator: John Breneman, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jeff Michalski, M.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02040467    
Other Study ID Numbers: 201209025
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No