SarcomaNCT07129317
Pediatric Radiation Therapy Registry
An observational study of Sarcoma and Pediatric Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 26 years
- Conditions the study is for
- Sarcoma, Pediatric Brain Tumors
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2025to Sep 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric brain tumor and bone and soft tissue sarcoma patients that are being treated with proton or photon radiation therapy.
Who may be able to join
- Treatment with either proton or photon radiation therapy.
Who cannot join
- Greater than 26 years old
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Ethan Arnone, BS, 202-919-2533, earnone3@jh.edu
Betsy Sawdy, MSN, eburne10@jh.edu
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Ethan Arnone, BS, 202-919-2533, earnone3@jh.edu
Betsy Sawdy, MSN, eburne10@jh.edu
About this study
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.
- Conditions
- Sarcoma, Pediatric Brain Tumors
- Keywords
- Pediatric, Brain tumor, Registry, Proton radiation, Radiation therapy, Photon radiation
- Medical subject headings
- Sarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured from date of diagnosis until death, obtained from medical record notes
Measured: 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
Measured: Approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start31 Oct 2025
- Primary completionSep 2035 (estimated)
- Study completionSep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Clark Charitable Foundation Inc.
- Responsible party
- Sponsor
- Investigators
- Sahaja Acharya, MD, Principal investigator, SKCCC Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129317
- Sponsor's protocol ID
- J2563
- Other IDs
- IRB00504065
- Status last verified
- Nov 2025
- First submitted
- 11 Aug 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Radiation Therapy Registry
- ClinicalTrials.gov ID
- NCT07129317
- Acronym / sponsor ID
- J2563
- Conditions
- Sarcoma, Pediatric Brain Tumors
- Keywords
- Pediatric, Brain tumor, Registry, Proton radiation, Radiation therapy, Photon radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Clark Charitable Foundation Inc.
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2040 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 0 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric brain tumor and bone and soft tissue sarcoma patients that are being treated with proton or photon radiation therapy.
Key inclusion criteria (1 listed)
- Treatment with either proton or photon radiation therapy.
Key exclusion criteria (1 listed)
- Greater than 26 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: Approximately 10 years
Measured from date of diagnosis until death, obtained from medical record notes
Toxicity due to Radiation Therapy as assessed by number of patients with adverse events
Time frame: Approximately 10 years
The number of patients that experience adverse events, obtained from medical record notes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahaja Acharya, MD principal investigator
SKCCC Johns Hopkins Medical Institution
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Pediatric Brain Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ethan Arnone, BS (2029192533, earnone3@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.