跳至主要内容
临床试验/NCT03224650
NCT03224650已完成不适用

Validation of Novel Predictive Score for Patients With Spinal Metastases

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
1
主要终点
EuroQuol 5-Dimension (EQ5D) profile

研究概览

简要总结

The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.

详细描述

Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age
  • Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
  • Able to consent for themselves at the time of the intake evaluation
  • Speaks English

排除标准

  • Primary bone tumors or leukemia
  • Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
  • History of prior spine surgery for metastatic disease

结局指标

主要结局

EuroQuol 5-Dimension (EQ5D) profile

时间窗: Up to 3 years

Assessment of state of health and physical/mental function

Survival

时间窗: Up to 3 years

Mortality is documented using date of death in medical record

Short-Form (SF)-12

时间窗: Up to 3 years

Assessment of state of health and physical/mental function

Visual Analog Scale (VAS) for pain

时间窗: Up to 3 years

Assessment of current level of pain

Patient-Reported Outcomes Measurement Information System (PROMIS)

时间窗: Up to 3 years

Assessment of global health

次要结局

  • Post-treatment morbidity and readmissions(Up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Schoenfeld

Associate Professor

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验