Treatment With Proton Beam Radiation TherapyNCT02986048
Proton Therapy Patient Registry
An observational study of Treatment With Proton Beam Radiation Therapy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to establish a database (or "registry") of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment With Proton Beam Radiation Therapy
- What is being tested?
- Proton Beam Therapy
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with proton beam at the UH Proton Therapy Center
Who may be able to join
- Patients treated with proton beam at the UH Proton Therapy Center
- Patients who have the ability to understand and be willing to sign a written informed consent document
Who cannot join
- Patients or legal guardians who are unable to understand informed consent document
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
David B Mansur, MD, 800-641-2422, CTUReferral@UHhospitals.org
David B Mansur, MD
About this study
The purpose of this study is to establish a database (or "registry") of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients.
Read the detailed description
The primary objective of this non-therapeutic registry study is to create a secure longitudinal database of patients treated with proton therapy at the UH Proton Therapy Center. This will allow reporting patient, tumor, and treatment characteristics as well as outcome data pertaining to disease control and complications for this relatively rare radiation modality.
- Being tested
- Proton Beam Therapy
- Keywords
- proton beam, registry, radiation, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam TherapyOther
Intervention is not assigned. Only patient data is being collected
| Study group | Role | What they receive |
|---|---|---|
| Proton Beam Therapy | All patients treated with proton beam therapy at the UH Proton Therapy Center who consent to have their health information recorded, including whether the cancer was cured and if any complications occur ed due to treatment Receives: Other: Proton Beam Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants treated at UH Proton Therapy Center by proton beam therapy
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start22 Nov 2016
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment With Proton Beam Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 999 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B Mansur, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986048
- Sponsor's protocol ID
- CASE4Y16
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2016
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy Patient Registry
- ClinicalTrials.gov ID
- NCT02986048
- Acronym / sponsor ID
- CASE4Y16
- Keywords
- proton beam, registry, radiation, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- 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 purpose of this study is to establish a database (or "registry") of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients.
Detailed description
The primary objective of this non-therapeutic registry study is to create a secure longitudinal database of patients treated with proton therapy at the UH Proton Therapy Center. This will allow reporting patient, tumor, and treatment characteristics as well as outcome data pertaining to disease control and complications for this relatively rare radiation modality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Therapy | – | Other: Proton Beam TherapyAll patients treated with proton beam therapy at the UH Proton Therapy Center who consent to have their health information recorded, including whether the cancer was cured and if any complications occur ed due to treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with proton beam at the UH Proton Therapy Center
Key inclusion criteria (2 listed)
- Patients treated with proton beam at the UH Proton Therapy Center
- Patients who have the ability to understand and be willing to sign a written informed consent document
Key exclusion criteria (1 listed)
- Patients or legal guardians who are unable to understand informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam TherapyIntervention is not assigned. Only patient data is being collected | Other | Proton Beam Therapy |
Primary outcome
Number of participants treated at UH Proton Therapy Center by proton beam therapy
Time frame: Up to 10 years
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 9 Apr 2026.
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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.
David B Mansur, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment With Proton Beam Radiation Therapy, run by Case Comprehensive Cancer Center at 1 site 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 2 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 David B Mansur, MD (1-800-641-2422, CTUReferral@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants treated at UH Proton Therapy Center by proton beam therapy (time frame: Up to 10 years). 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 9 Apr 2026.