Registry Study for Proton Therapy Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01255748
First received: December 6, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

The purpose of this research study is to collect and analyze information from patients being treated with proton therapy.


Condition Intervention
Solid Tumors
Radiation: Proton Therapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Proton Therapy

Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • Define outcomes for patients treated at participating institutions [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures [ Time Frame: Annually PRN ] [ Designated as safety issue: Yes ]
  • Improve patient care by an adequate understanding of the results and patient population at participating institutions [ Time Frame: Reviewed Annually PRN ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: June 2009
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment with Proton Therapy Radiation: Proton Therapy
Outcomes Tracking

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Planned treatment with proton radiation
  • Ability to understand and sign IRB approved consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255748

Contacts
Contact: Megan Dunn, PhD,MSHS 630-657-0092 mdunn@pcgresearch.org

Locations
United States, California
Scripps Health Proton Center Recruiting
San Diego, California, United States, 92121
Contact: Eileen Anderson    858-549-7524    anderson.eileen@scrippshealth.org   
Principal Investigator: Carl Rossi, MD         
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Research Coordinator    630-821-6397      
Principal Investigator: William Hartsell, MD         
United States, New Jersey
ProCure Proton Therapy Center Recruiting
Somerset, New Jersey, United States, 08873
Contact: Carl Brown    732-357-2676    carl.brown@nj.procure.com   
Principal Investigator: Brian Chon, MD         
United States, Oklahoma
ProCure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tisha Adams, MS,CCRC    405-773-6775    tisha.adams@okc.procure.com   
Principal Investigator: Gary Larson, MD         
United States, Virginia
Hampton University Proton Therapy Institute Recruiting
Hampton, Virginia, United States, 23666
Contact: Scott Acker    757-251-6856    scott.acker@hamptonproton.org   
Principal Investigator: Christopher Sinesi, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195-6043
Contact: Jennifer Revall    206-598-8629    jrevall@uw.edu   
Principal Investigator: George Laramore, MD         
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Carlos Vargas, MD Proton Collaborative Group
  More Information

Additional Information:
No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01255748     History of Changes
Other Study ID Numbers: REG001-09
Study First Received: December 6, 2010
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
cancer, proton, radiation

ClinicalTrials.gov processed this record on October 19, 2014