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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

Official Title

Metastatic Tumor Research and Outcome Network A Multicenter Prospective Registry for the Management and Outcome of Metastatic Spine Tumors

Details

To prospectively determine the prognostic variables (clinical, diagnostic, and therapeutic) within patients diagnosed with metastatic spine tumor(s) that are associated with:

  • patient reported outcomes (HRQOL)
  • morbidity data
  • local tumor control
  • survival

Outcome measures:

Variables which will be collected in the registry that are applicable to patients with metastatic spine tumor include:

  • • Patient details
  • Details of previous treatment
  • Diagnosis
  • Symptoms
  • Treatment details for the index target
  • Imaging information

The following outcome measures will be collected:

  • Patient reported outcomes:
  • Euroqol EQ-5D-3L
  • Euroqol EQ-5D VAS - Quality of Life
  • Neck Pain Numeric Rating Scale (NRS)
  • Arm Pain NRS
  • Back Pain NRS
  • Leg Pain NRS
  • SOSGOQ
  • Patient assessment
  • Ambulation
  • Pain medication
  • Nutritional Status Tool (PG-SGA©)
  • Morbidity data
  • Local disease recurrence data
  • Overall survival data

Keywords

Metastatic Spine Tumor Registry Spine Surgery Medical Oncology Radiation Oncology Neoplasms Metastasis Chemotherapy Radiation Therapy Tumor Markers Neoplasm Metastasis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient 18 or older.
  • Patient diagnosed with a metastatic tumor of the spine
  • 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
  • Signed and dated EC/IRB approved written informed consent (if consent is required by the EC/ IRB at the registry site)

You CAN'T join if...

• Patient diagnosed with a primary tumor of the spine.

Locations

  • University of California The UCSF Spine Center Department of Neurological Surgery not yet accepting patients
    San Francisco, California, 94143, United States
  • Vancouver General Hospital and the University of British Columbia not yet accepting patients
    Vancouver, British Columbia, V5Z 1M9, Canada
  • Winnipeg Spine Program University of Manitoba Department of Surgery not yet accepting patients
    Winnipeg, Manitoba, R3A 1R9, Canada
  • The University of Texas MD Anderson Cancer Center Department of Neurosurgery not yet accepting patients
    Houston, Texas, 77030, United States
  • Mayo Clinic Department of Neurosurgery not yet accepting patients
    Rochester, Minnesota, 55905, United States
  • Rush University Medical Center University Neurosurgery not yet accepting patients
    Chicago, Illinois, 60612, United States
  • Toronto Western Hospital Department of Neurosurgery Division of Surgery not yet accepting patients
    Toronto, Ontario, 4W449, Canada
  • University of Toronto Odette Cancer Centre - T2 158 Sunnybrook Health Sciences Ccenter not yet accepting patients
    Toronto, Ontario, M4N 3M5, Canada
  • University of Rochester School of Medicine and Dentistry Department of Orthopaedic Surgery and Neurosurgery not yet accepting patients
    Rochester, New York, 14642, United States
  • Johns Hopkins University Department of Neurosurgery / Spine Division not yet accepting patients
    Baltimore, Maryland, 21205, United States
  • Penn Presbyterian Medical Center Department of Neurosurgery not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • McGill University Health Centre not yet accepting patients
    Montréal, Quebec, H3G 1A4, Canada
  • Memorial Sloan-Kettering Cancer Center not yet accepting patients
    New York, New York, 10065, United States
  • Westchester Medical Center Department of Neurosurgery
    Valhalla, New York, 10595, United States
  • The Warren Alpert Medical School of Brown university Department of Neurosurgery not yet accepting patients
    Providence, Rhode Island, 02903, United States
  • Harvard Medical School Department of Neurosurgery not yet accepting patients
    Boston, Massachusetts, 02114, United States
  • Kanazawa Medical University Hospital Department of Orthopaedic Surgery not yet accepting patients
    Uchinada, Ishikawa, 920-0293, Japan
  • Universitair Medisch Centrum Utrecht not yet accepting patients
    Utrecht, 3508, Netherlands
  • Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden not yet accepting patients
    Dresden, Sachsen, 01307, Germany
  • Universitätsspital Basel Wirbelsäulenzentrum not yet accepting patients
    Basel, 4031, Switzerland
  • National Center for Spinal Disorders and Buda Health Center not yet accepting patients
    Budapest, 1126, Hungary
  • Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery
    Bologna, Emilia-Romagna, 40136, Italy
  • IRCCS Istituto Ortopedico Galeazzi Centro die Chirurgia Ortopedica Oncologica e Ricostr not yet accepting patients
    Milano, Lombardei, 20161, Italy
  • Monash University Melbourne not yet accepting patients
    Clayton, Victoria, 3168, Australia
  • National University of Singapore Department of Orthopaedic Surgery not yet accepting patients
    Singapore, 119288, Singapore

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AO Clinical Investigation and Documentation
ID
NCT02830451
Lead Scientist
Dean Chou
Study Type
Observational [Patient Registry]
Last Updated
November 28, 2017
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