NCT07129317

Brief Summary

The Johns Hopkins Pediatric Radiation Oncology Program is creating a registry that will capture the full 3D radiation dosimetry delivered to its pediatric patients to manage the quality of care provided, as well as to examine the long-term outcomes and toxicity of each patient. The registry will capture baseline clinical data, disease, toxicity, and quality of life outcomes. The goal is to include all pediatric patients undergoing proton therapy and photon therapy to enable future comparisons of treatment outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
175mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Oct 2025Sep 2040

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2025

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2040

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

9.8 years

First QC Date

August 11, 2025

Last Update Submit

November 4, 2025

Conditions

Keywords

PediatricBrain tumorRegistryProton radiationRadiation therapyPhoton radiation

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    Measured from date of diagnosis until death, obtained from medical record notes

    Approximately 10 years

  • Toxicity due to Radiation Therapy as assessed by number of patients with adverse events

    The number of patients that experience adverse events, obtained from medical record notes

    Approximately 10 years

Study Arms (3)

Pediatric brain tumors

Pediatric patients diagnosed with brain tumors requiring treatment with either proton or photon radiation therapy.

Pediatric sarcomas

Pediatric patients diagnosed with bone or soft tissue sarcomas requiring treatment with either proton or photon radiation therapy.

Non-brain-tumor and non-sarcoma

Eligibility Criteria

Age0 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric brain tumor and bone and soft tissue sarcoma patients that are being treated with proton or photon radiation therapy.

You may qualify if:

  • Treatment with either proton or photon radiation therapy.

You may not qualify if:

  • Greater than 26 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sibley Memorial Hospital

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

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

SarcomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sahaja Acharya, MD

    SKCCC Johns Hopkins Medical Institution

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethan Arnone, BS

CONTACT

Betsy Sawdy, MSN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

October 31, 2025

Primary Completion (Estimated)

September 1, 2035

Study Completion (Estimated)

September 1, 2040

Last Updated

November 5, 2025

Record last verified: 2025-11

Locations