Proton Radiation Therapy Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer, Therapy-Related
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Akila Viswanathan, MD; Phone Number: 410-502-1421; Email: anv@jhmi.edu
• Study Contact Backup: Name: Dana Kaplin, MPH; Phone Number: 410-614-3950; Email: dkaplin1@jhmi.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
      • Contact: Akila Viswanathan, MD; Phone Number: 410-502-1421; Email: anv@jhmi.edu
      • Contact: Dana Kaplin, MPH; Phone Number: 41--614-3950; Email: dkaplin1@jhmi.edu
    • Washington, District of Columbia, United States, 20814
      • Recruiting
      • Suburban Hospital
      • Contact: Akila Viswanathan, MD; Phone Number: 410-502-1421; Email: anv@jhmi.edu
      • Contact: Dana Kaplin, MPH; Phone Number: 410-614-3950; Email: dkaplin1@jhmi.edu
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Akila Viswanathan, MD; Phone Number: 410-502-1421; Email: anv@jhmi.edu
      • Contact: Dana Kaplin, MPH; Phone Number: 410-614-3950; Email: dkaplin1@jhmi.edu
      • Sub-Investigator: Zhi Cheng, MD
      • Sub-Investigator: Todd McNutt, PhD
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Bayview Hospital
      • Contact: Dana Kaplin, MPH; Phone Number: 410-614-3950; Email: dkaplin1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

cancer patients with proton therapy

Description

Inclusion Criteria:

• All patients treated at the proton center.

Exclusion Criteria:

• Any other than what is supplied in the inclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research registry of cancer patients receiving proton radiation therapy	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.	15 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Akila Viswanathan, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2040

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: proton therapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: J2008; IRB00228501 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No