Proton Radiation Therapy Registry

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Recruiting

CT.gov ID

NCT04376229

Collaborator

(none)

5,000

Enrollment

Locations

120

Anticipated Duration (Months)

1250

Patients Per Site

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Therapy-Related	Other: Registry

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Proton Radiation Therapy Registry

Actual Study Start Date :

Apr 7, 2020

Anticipated Primary Completion Date :

Apr 7, 2027

Anticipated Study Completion Date :

Apr 7, 2030

Arms and Interventions

Arm	Intervention/Treatment
Cancer patients receiving proton radiation therapy Registry of cancer patients who receive proton radiation therapy to track disease and toxicity outcomes.	Other: Registry Registry of cancer patients who receive proton radiation therapy

Arm

Intervention/Treatment

Cancer patients receiving proton radiation therapy

Registry of cancer patients who receive proton radiation therapy to track disease and toxicity outcomes.

Other: Registry

Registry of cancer patients who receive proton radiation therapy

Outcome Measures

Primary Outcome Measures

Research registry of cancer patients receiving proton radiation therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients treated at the proton center.

Exclusion Criteria:

Any other than what is supplied in the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
2	Suburban Hospital	Washington	District of Columbia	United States	20814
3	Bayview Hospital	Baltimore	Maryland	United States	21224
4	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

Principal Investigator: Akila Viswanathan, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

ClinicalTrials.gov Identifier:

NCT04376229

Other Study ID Numbers:

J2008
IRB00228501

First Posted:

May 6, 2020

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

proton therapy

Additional relevant MeSH terms:

Neoplasms, Second Primary

Study Results

No Results Posted as of Sep 5, 2021