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Recruiting

NCT Number: NCT02070328

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

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.

Recruiting

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Ackerman Cancer Center, Jacksonville, Florida, United States

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About this study

The objective of this research protocol is the development of a national Proton Therapy Center Registry for the purpose of:

  • Performing retrospective research studies on diseases treated with proton therapy throughout the United States.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registry

Other

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

James R Gray, M.D.

CONTACT

[email protected]

(865) 934-2672

Kristi Simcox, BS, CCRP

CONTACT

[email protected]

(865) 934-2672

Sponsors and collaborators

Lead sponsor

Center for Biomedical Research, LLC

Other

Collaborators

  • Provision Center for Proton Therapy

Registry information

Acronym: Registry

Important dates

Study start
2013
Primary completion
2050
Study completion
2050
First posted
Feb 25, 2014
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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