RecruitingNCT02790983

Primary Tumor Research and Outcomes Network

Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine


Sponsor

AO Innovation Translation Center

Enrollment

1,350 participants

Start Date

Oct 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.


Eligibility

Inclusion Criteria7

  • Patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. This includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.).
  • Informed consent obtained, i.e.:
  • Ability to understand the content of the patient information/ICF
  • Willingness and ability to participate in the registry according to the Registry Plan (RP)
  • Signed and dated EC/IRB approved written informed consent
  • OR
  • Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria1

  • \- Patient diagnosed with a metastatic tumor of the spine.

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Locations(19)

University of California

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

University of Queensland, School of Medicine

Brisbane, Australia

Vancouver General Hospital and the University of British Columbia

Vancouver, British Columbia, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Peking University 3rd Hospital

Beijing, Beijing Municipality, China

Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden

Dresden, Germany

National Center for Spinal Disorders and Buda Health Center

Budapest, Hungary

Istituto Ortopedico Rizzoli

Bologna, Italy

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Kanazawa Medical University Hospital

Kanazawa, Japan

Oxford University Hospitals

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02790983