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

NCT ID: NCT02070328

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2050-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation therapy Registry

Cancer patients who have received proton therapy

Registry

Intervention Type OTHER

Interventions

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Registry

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Provision Center for Proton Therapy

OTHER

Sponsor Role collaborator

Center for Biomedical Research, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Gray, M.D.

Role: PRINCIPAL_INVESTIGATOR

Provision Center for Proton Therapy

Locations

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Ackerman Cancer Center

Jacksonville, Florida, United States

Site Status RECRUITING

Provision CARES Proton Therapy Nashville

Franklin, Tennessee, United States

Site Status RECRUITING

Texas Center for Proton Therapy

Irving, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristi Simcox, BS, CCRP

Role: CONTACT

(865) 934-2672

James R Gray, M.D.

Role: CONTACT

(865) 934-2672

Facility Contacts

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Michele Katz, CRC

Role: primary

904-880-5522

Cate Bernatt, CRA

Role: backup

904-880-5522

Kristi Simcox, BS, CCRP

Role: primary

865-934-2672

Vanetta G. Zollicoffer, CCRC

Role: primary

469-513-5531

Related Links

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http://provisionproton.com

Provision Center for Proton Therapy

Other Identifiers

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PRO 0425

Identifier Type: -

Identifier Source: org_study_id

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