跳至主要内容
临床试验/NCT01210508
NCT01210508终止不适用

A Prospective Analysis of the Tokuhashi Score and Its Effectiveness in Guiding Treatment and Predicting Survival in Patients With Metastases Spread to the Spine

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
1
主要终点
To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases

研究概览

简要总结

70% of all cancer patients develop some form of visceral (internal organs) or skeletal metastases (spread of disease). Approximately one third of cancer patients develop metastases to the spinal column. The prognosis once spinal metastases have been diagnosed and the most appropriate treatment still remains controversial. To date there is no one good diagnostic tool to predict survival and/or outcome after radiotherapy or surgical intervention.

Tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate indications for surgery and predict outcome in patients with metastases to the spinal column. Six variables are measured to calculate this score: general medical condition, number of extraspinal metastases, number of vertebral metastases, status of metastases to the major internal organs, primary tumor type, and presence of a neurologic deficit. This scoring system has been gaining acceptance in literature. In 1998, Tokuhashi, et al, modified this scoring system by diversifying the tumor types into six categories. After a retrospective analysis Tokuhashi reported that patients with scores less than or equal to 8 will die of their disease within 6 months and those with scores of 12 or greater will survive an average of 12 months or more.

The purpose of this study is to determine 1) the Tokuhashi score's validity in predicting survival after developing spinal metastases, 2) the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score. Patients will be enrolled into the study and followed prospectively for as long as possible regardless of intervention.

There will be three groups based on their Tokuhashi score, each group will require approximately 163 subjects statistically.

详细描述

all info is in brief summary

研究设计

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

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients diagnosed with any form of spinal metastases, whether symptomatic or not, regardless of tumor biology, and seen by a physician in the Department of Orthopedic Surgery, will be asked to enter this trial.
  • Must be a patient of our practice

排除标准

  • There is no exclusion criteria

结局指标

主要结局

To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases

时间窗: 24 months

will follow subjects until death

次要结局

  • the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score(24 months)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

William Lavelle

Associate Professor

State University of New York - Upstate Medical University

研究点 (1)

Loading locations...

相似试验