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Clinical Trials/NCT01210508
NCT01210508
Terminated
Not Applicable

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 site in 1 country2 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
State University of New York - Upstate Medical University
Enrollment
2
Locations
1
Primary Endpoint
To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

all info is in brief summary

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University
Responsible Party
Principal Investigator
Principal Investigator

William Lavelle

Associate Professor

State University of New York - Upstate Medical University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • There is no exclusion criteria

Outcomes

Primary Outcomes

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

Time Frame: 24 months

will follow subjects until death

Secondary Outcomes

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

Study Sites (1)

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