NCT02070328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
287mo left

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2013Jan 2050

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
35.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2050

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

36.1 years

First QC Date

January 14, 2014

Last Update Submit

February 6, 2023

Conditions

Keywords

Proton TherapyRegistry

Outcome Measures

Primary Outcomes (1)

  • Long-term follow-up

    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.

    6 months

Secondary Outcomes (1)

  • Future Research Possibilities

    12 months

Study Arms (1)

Radiation therapy Registry

Cancer patients who have received proton therapy

Other: Registry

Interventions

Radiation therapy Registry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are seen/treated at proton therapy centers

You may qualify if:

  • All subjects who are receiving or seeking medical care at the participating Proton Therapy Center will be invited to participate in the Research Registry.

You may not qualify if:

  • Subjects who do not agree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ackerman Cancer Center

Jacksonville, Florida, 32223, United States

RECRUITING

Provision CARES Proton Therapy Nashville

Franklin, Tennessee, 37067, United States

RECRUITING

Texas Center for Proton Therapy

Irving, Texas, 75063, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • James R Gray, M.D.

    Provision Center for Proton Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

February 25, 2014

Study Start

December 1, 2013

Primary Completion (Estimated)

January 1, 2050

Study Completion (Estimated)

January 1, 2050

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations