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Active (not recruiting) NCT02830451

Metastatic Tumor Research and Outcomes Network

Conditions: Metastatic Spine Tumor

Sponsor: AO Innovation Translation Center

trial.available_in: БГ
Overview
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).
Description
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
Who can participate
Inclusion Criteria: * 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) Exclusion Criteria: • Patient diagnosed with a primary tumor of the spine.
Locations 10
Australia (1)
Monash University Melbourne
Clayton , Victoria
Canada (1)
Vancouver General Hospital and the University of British Columbia
Vancouver , British Columbia
Germany (1)
Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden , Saxony
Hungary (1)
National Center for Spinal Disorders and Buda Health Center
Budapest
Italy (1)
Instituto Ortopedico Rizzoli Department of Oncologic and Degenerative Spine Surgery
Bologna , Emilia-Romagna
Japan (1)
Kanazawa Medical University Hospital Department of Orthopaedic Surgery
Uchinoda , Ishikawa-ken
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht
Singapore (1)
National University of Singapore Department of Orthopaedic Surgery
Singapore
Switzerland (1)
Universitätsspital Basel Wirbelsäulenzentrum
Basel , Basel
United States (1)
University of California The UCSF Spine Center Department of Neurological Surgery
San Francisco , California
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.11.2017
Completion date
15.08.2026
Registry ID
NCT02830451
Source
anzctr
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