Duke Spine Outcome Study (DSOS)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Change in Quality of Life as measured by SF-36 version 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years.
- •Able to read and write local language at an elementary level.
- •Diagnosis of primary or metastatic tumor of the spine ); or
- •Infection of the spine; or
- •Instability of the spine; or
- •Injury of the spine.
- •Accessibility for treatment and follow up.
- •Patient consent obtained according to Duke institutional policy.
- •Inclusion criteria for spine surgery (control population for bone marrow specimens)
- •Age between 18 and 85 years.
- •Spine surgery to be performed at Duke University Medical Center (DUMC) under the auspices of the neurosurgery program.
- •No concurrent cancer diagnosis.
- •Accessibility for treatment and follow up.
- •Patient consent obtained according to Duke institutional policy.
排除标准
- •History of substance abuse (recreational drugs, alcohol) within 12 months prior to screening
- •Is a prisoner.
- •A disease or condition that would, in opinion of the investigator, preclude accurate evaluation
- •(e.g. significant psychiatric disease), or that would impair the ability of the patient to receive protocol treatment or comply with protocol.
- •Pregnant or breast feeding during the study period (women of child-bearing potential will require a negative serum pregnancy test within 30 days of enrollment).
- •Active infection, or fever of unknown origin.
- •Inflammatory bowel disease.
- •Systemic lupus erythematosus.
- •Rheumatoid arthritis, or other autoimmune disease.
- •History of or active hematologic or bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition.
- •Polycythemia vera.
- •Known or suspected immunodeficiency or Human Immunodeficiency Virus (HIV).
- •Hematocrit < 24% pre-operatively.
结局指标
主要结局
Change in Quality of Life as measured by SF-36 version 2
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
Short-form health survey with 36 questions
Change in Quality of Life as measured by Spine Cancer Outcomes Questionnaire (SCOQ)
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
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.
Change in Pain Score as measured by Pain Numeric Rating Scale (NRS)
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
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.
Change in Neurological Function as measured by International Standards Neurological Classification of Spinal Cord Injury (ISNCSCI)
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit.
Change in Health Status as measured by EQ-5D
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
It contains 5 questions and provides a simple descriptive profile and a single index value for health status.
Change in Daily Living Abilities as measured by Eastern Cooperative Oncology Group (ECOG) Performance Status
时间窗: Baseline, 6, 12, 26, 52, 104 weeks
Grade 0 = Fully active to 5 = Dead
次要结局
未报告次要终点