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

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ClinicalTrials.gov Identifier: NCT02070328
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Provision Center for Proton Therapy
Information provided by (Responsible Party):
Center for Biomedical Research, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer 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 [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 25 Years
Official Title: Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
Study Start Date : December 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

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



Primary Outcome Measures :
  1. Long-term follow-up [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Future Research Possibilities [ Time Frame: 12 months ]

    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.




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
Patients who are seen/treated at proton therapy centers
Criteria

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

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): NCT02070328


Contacts
Contact: Susie T Owenby, RN, CCRP 865-934-2672 sowenby@biomed-research.com
Contact: J. Ben Wilkinson, M.D. 865-934-2670 ben.wilkinson@provisionproton.com

Locations
United States, Florida
Ackerman Cancer Center Recruiting
Jacksonville, Florida, United States, 32223
Contact: Ryan S Perkins, MD    904-880-5522      
Contact: Nick Giancola, MBA    904-880-5522    nick@ackermancancer.com   
United States, Tennessee
Provision Center for Proton Therapy Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Susan Owenby, RN    865-934-2670    sowenby@biomed-research.com   
Principal Investigator: J. Ben Wilkinson, MD         
United States, Texas
Texas Center for Proton Therapy Recruiting
Irving, Texas, United States, 75063
Contact: Lashundra N. Coleman, BS    469-513-5500    Lashundra.coleman@usoncology.com   
Principal Investigator: Andrew K. Lee, MD         
Sponsors and Collaborators
Center for Biomedical Research, LLC
Provision Center for Proton Therapy
Investigators
Principal Investigator: J. Ben Wilkinson, M.D. Provision Center for Proton Therapy

Additional Information:
Responsible Party: Center for Biomedical Research, LLC
ClinicalTrials.gov Identifier: NCT02070328     History of Changes
Other Study ID Numbers: PRO 0425
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Center for Biomedical Research, LLC:
Proton Therapy
Registry