Proton Therapy Patient Registry | NCT02986048

Studies
Proton Therapy Patient Registry

NCT02986048

Sponsor

Case Comprehensive Cancer Center

Status

Recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

999Estimated

Phase

Not provided

Conditions

Treatment With Proton Beam Radiation Therapy

Interventions

Proton Beam Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2016Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Dec 6, 2016

First Submission Date that Met QC Criteria

Dec 6, 2016

First Posted Date

Dec 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

999Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Other: Proton Beam Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proton Beam Therapy	Other	Intervention is not assigned. Only patient data is being collected	Proton Beam Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants treated at UH Proton Therapy Center by proton beam therapy		Up to 10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients or legal guardians who are unable to understand informed consent document

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients treated with proton beam at the UH Proton Therapy Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David B Mansur, MD	Contact	1-800-641-2422		CTUReferral@UHhospitals.org

Overall Officials

Name	Affiliation	Role
David B Mansur, MD	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Recruiting	Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061766	Proton Therapy

Ancestor Terms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided