The primary goal of this registry is to increase the knowledge about spine tumors and other spine disorders to guide appropriate management strategies for the future. This registry will include the review of medical records, data collection for health related quality of life questionnaires, and collected tissues and samples. The study will require obtaining spinal lesions (tumor, etc.), blood, and bone marrow samples (from non-lesional bone) from selected patients, which will be collected during your surgery.
Study Type
OBSERVATIONAL
Enrollment
900
Duke University Medical Center
Durham, North Carolina, United States
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
It is made up of 5 domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the 36-Item Short Form Survey (SF-36) for patients with spine tumors. The reliability and validity of this questionnaire will be compared with the SF-36v2.
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
Change in Quality of Life as measured by SF-36 version 2
Short-form health survey with 36 questions
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
Change in Health Status as measured by EQ-5D
It contains 5 questions and provides a simple descriptive profile and a single index value for health status.
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 = Fully active to 5 = Dead
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)
ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.
Time frame: Baseline, 6, 12, 26, 52, 104 weeks
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