Proton Therapy Patient Registry

February 29, 2024 updated by: Case Comprehensive Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • David B Mansur, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Intervention is not assigned. Only patient data is being collected

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: David B Mansur, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2016

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimated)

December 8, 2016

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CASE4Y16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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