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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients will be collected and evaluated to investigate the prognostic factors which influence survival, local recurrence, adverse events, perioperative morbidity, and HRQOL in subgroups of patients diagnosed with primary spinal column tumors.

Official Title

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

Details

Objective: To prospectively investigate the prognostic variables (clinical, diagnostic, and therapeutic) within subgroups of patients diagnosed with primary spinal column tumors that are associated with:

  • survival
  • local recurrence
  • perioperative morbidity
  • patient reported outcomes

Outcome measures: Variables applicable to primary spinal column tumor patients which will be collected in the registry include:

  • Patient details
  • Treatment status
  • Details of previous treatment
  • Diagnosis and biopsy types
  • Tumor details
  • Oncological staging
  • Symptoms
  • Treatment details
  • Imaging information

The investigators aim to collect the following outcome measures:

  • Overall survival data
  • Local disease recurrence data
  • Perioperative morbidity data

Patient reported outcomes:

  • Euroqual-5D-3L
  • Euroquol EQ-5D VAS - Quality of Life
  • Neck pain numeric rating scale (NRS)
  • Arm pain NRS
  • Back pain NRS
  • Leg Pain NRS
  • SF-36 version 2
  • SOSG Outcome Questionnaire

Keywords

Spinal Column Tumor Registry Spine Surgery Medical Oncology Radiation Oncology Neoplasms

Eligibility

You can join if…

  • Patient diagnosed with a primary tumor of the spine who receive medical and/or surgical treatment for the tumor.
  • Patient willing and able to participate in the registry and able to attend follow-up visits, according to the investigator.
  • Patient capable of understanding the content of the patient information and Informed Consent Form (if consent is required by the EC/ IRB at the registry site).
  • Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki.

You CAN'T join if...

  • Patient diagnosed with a metastatic tumor of the spine.
  • Patient diagnosed with a primary spinal cord tumor.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco, California, CA 94134, United States
  • Vancouver General Hospital and the University of British Columbia accepting new patients
    Vancouver, British Columbia, V5Z 1M9, Canada
  • The University of Texas M.D. Anderson Cancer Center accepting new patients
    Houston, Texas, 77030, United States
  • Mayo Clinic accepting new patients
    Rochester, Minnesota, 55905, United States
  • Toronto Western Hospital accepting new patients
    Toronto, Ontario, M5T 2S8, Canada
  • Johns Hopkins University School of Medicine accepting new patients
    Baltimore, Maryland, MD 21205, United States
  • Memorial Sloan-Kettering Cancer Center not yet accepting patients
    New York, New York, NY 10065, United States
  • Rhode Island Hospital accepting new patients
    Providence, Rhode Island, 02903, United States
  • Massachusetts General Hospital not yet accepting patients
    Boston, Massachusetts, 02114, United States
  • Oxford University Hospitals accepting new patients
    Oxford, OX3 7HE, United Kingdom
  • Kanazawa Medical University Hospital accepting new patients
    Kanazawa, 920-8641, Japan
  • Universitaetsklinikum Carl Gustav Carus der Techn. Universitaet - Dresden accepting new patients
    Dresden, 1307, Germany
  • National Center for Spinal Disorders and Buda Health Center accepting new patients
    Budapest, 1126, Hungary
  • Istituto Ortopedico Rizzoli accepting new patients
    Bologna, 40136, Italy
  • IRCCS Istituto Ortopedico Galeazzi accepting new patients
    Milano, 20161, Italy
  • Peking University 3rd Hospital not yet accepting patients
    Beijing, Beijing, 100191, China
  • University of Queensland, School of Medicine currently not accepting new patients, but might later
    Brisbane, 4000 QLD, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AO Clinical Investigation and Documentation
ID
NCT02790983
Study Type
Observational [Patient Registry]
Last Updated
November 16, 2017
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