Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
960 participants
OBSERVATIONAL
2017-11-15
2025-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AO Foundation, AO Spine
OTHER
AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Charles G. Fisher, MD
Role: PRINCIPAL_INVESTIGATOR
Vancouver General Hospital and the University of British Columbia
Locations
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University of California The UCSF Spine Center Department of Neurological Surgery
San Francisco, California, United States
Rush University Medical Center University Neurosurgery
Chicago, Illinois, United States
Johns Hopkins University Department of Neurosurgery / Spine Division
Baltimore, Maryland, United States
Harvard Medical School Department of Neurosurgery
Boston, Massachusetts, United States
Mayo Clinic Department of Neurosurgery
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Rochester School of Medicine and Dentistry Department of Orthopaedic Surgery and Neurosurgery
Rochester, New York, United States
Westchester Medical Center Department of Neurosurgery
Valhalla, New York, United States
Penn Presbyterian Medical Center Department of Neurosurgery
Philadelphia, Pennsylvania, United States
The Warren Alpert Medical School of Brown university Department of Neurosurgery
Providence, Rhode Island, United States
The University of Texas MD Anderson Cancer Center Department of Neurosurgery
Houston, Texas, United States
Monash University Melbourne
Clayton, Victoria, Australia
Vancouver General Hospital and the University of British Columbia
Vancouver, British Columbia, Canada
Winnipeg Spine Program University of Manitoba Department of Surgery
Winnipeg, Manitoba, Canada
Toronto Western Hospital Department of Neurosurgery Division of Surgery
Toronto, Ontario, Canada
University of Toronto Odette Cancer Centre - T2 158 Sunnybrook Health Sciences Ccenter
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden, Saxony, Germany
National Center for Spinal Disorders and Buda Health Center
Budapest, , Hungary
Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery
Bologna, Emilia-Romagna, Italy
IRCCS Istituto Ortopedico Galeazzi Centro die Chirurgia Ortopedica Oncologica e Ricostr
Milan, Lombardy, Italy
Kanazawa Medical University Hospital Department of Orthopaedic Surgery
Uchinoda, Ishikawa-ken, Japan
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
National University of Singapore Department of Orthopaedic Surgery
Singapore, , Singapore
Universitätsspital Basel Wirbelsäulenzentrum
Basel, Basel, Switzerland
Countries
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Other Identifiers
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MTRON
Identifier Type: -
Identifier Source: org_study_id