Proton Radiation Therapy Registry

NCT ID: NCT04376229

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-07
• Study Completion Date: 2040-12-31

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.

Conditions

Cancer, Therapy-Related

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer patients receiving proton radiation therapy

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

Registry

Intervention Type: OTHER

Registry of cancer patients who receive proton radiation therapy

Interventions

Registry

Registry of cancer patients who receive proton radiation therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients treated at the proton center.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtiland Deville, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Suburban Hospital

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Bayview Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Akila Viswanathan, MD

Role: CONTACT

anv@jhmi.edu

410-502-1421

Dana Kaplin, MPH

Role: CONTACT

dkaplin1@jhmi.edu

410-614-3950

Facility Contacts

Akila Viswanathan, MD

Role: primary

anv@jhmi.edu

410-502-1421

Dana Kaplin, MPH

Role: backup

dkaplin1@jhmi.edu

41--614-3950

Akila Viswanathan, MD

Role: primary

anv@jhmi.edu

410-502-1421

Dana Kaplin, MPH

Role: backup

dkaplin1@jhmi.edu

410-614-3950

Dana Kaplin, MPH

Role: primary

dkaplin1@jhmi.edu

410-614-3950

Akila Viswanathan, MD

Role: primary

anv@jhmi.edu

410-502-1421

Dana Kaplin, MPH

Role: backup

dkaplin1@jhmi.edu

410-614-3950

Other Identifiers

IRB00228501

Identifier Type: OTHER

Identifier Source: secondary_id

J2008

Identifier Type: -

Identifier Source: org_study_id