跳至主要内容
临床试验/NCT01643174
NCT01643174已完成不适用

Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine: A Multi-center Retrospective Cohort Study With a Cross-Sectional Survival Check

AO Foundation, AO Spine1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,600
试验地点
1
主要终点
overall survival

研究概览

简要总结

Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

详细描述

Primary tumors of the spine are exceedingly rare and therefore the literature has been limited to case series of limited size and significant heterogeneity. These tumors comprise 11% of all Primary Musculoskeletal Tumors and 4.2% of all spine tumors. Of all primary spine tumors only 6% are malignant, but it is the malignant tumors that present the greatest therapeutic challenges. Through this multi-center retrospective cohort study performed at 13 spine oncology referral, data on at least 2.000 patients with specific primary benign and malignant spine tumors will be collected. This will provide power to determine the influence of many previously hypothesized variables on outcome.

The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. These data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically.
  • At least one follow-up detectable in the medical charts

排除标准

  • metastatic tumor of the spine
  • primary spinal cord tumor

结局指标

主要结局

overall survival

时间窗: Average of 10 years

次要结局

  • local recurrence(Average of 10 years)

研究者

发起方
AO Foundation, AO Spine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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