Proton Radiation Therapy Registry

NCT04376229 | Recruiting

• 2 other identifiers: J2008IRB00228501
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer, Therapy-Related

Keywords

proton therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cancer patients receiving proton radiation therapy

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

Other: Registry

Interventions

Registry OTHER

Registry of cancer patients who receive proton radiation therapy

Cancer patients receiving proton radiation therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cancer patients with proton therapy

You may qualify if:

• All patients treated at the proton center.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (4)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Suburban Hospital

Washington D.C., District of Columbia, 20814, United States

RECRUITING

Bayview Hospital

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms, Second Primary

Interventions

Registries

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Curtiland Deville, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akila Viswanathan, MD

CONTACT

410-502-1421; anv@jhmi.edu

Dana Kaplin, MPH

CONTACT

410-614-3950; dkaplin1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 6, 2020
• Study Start: April 7, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2040
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)