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Clinical Trials/NCT04376229
NCT04376229
Recruiting
Not Applicable

Proton Radiation Therapy Registry

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 sites in 1 country5,000 target enrollmentApril 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer, Therapy-Related
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment
5000
Locations
4
Primary Endpoint
Research registry of cancer patients receiving proton radiation therapy
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

Detailed Description

Proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. The clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. Establishing the clinical efficacy of proton therapy requires years of experience treating patients. The goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Registry
clinicaltrials.gov
Start Date
April 7, 2020
End Date
December 1, 2040
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • All patients treated at the proton center.

Exclusion Criteria

  • Any other than what is supplied in the inclusion criteria

Outcomes

Primary Outcomes

Research registry of cancer patients receiving proton radiation therapy

Time Frame: 15 years

This is a clinic based registry of cancer patients' data from participants to be collected over 15 years. The registry will be populated with 3D anatomy and radiation dosimetry from the RayStation treatment planning system used to plan all proton therapy patients. Clinical data will be extracted electronically from the MOSAIQ oncology information system used to manage the radiation therapy treatments. Structured clinical assessments will be routinely captured in the clinical workflow during patient encounters. Patient reported outcomes will be captured with iPad's using the OncoBrowser tools developed in radiotherapy that also interface with MOSAIQ.

Study Sites (4)

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