Clinical Trials Directory

Trials / Terminated

TerminatedNCT01210508

Analysis of Tokuhashi Score

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

Status
Terminated
Phase
Study type
Observational
Enrollment
2 (actual)
Sponsor
State University of New York - Upstate Medical University · Academic / Other
Sex
All
Age
10 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2009-03-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2010-09-28
Last updated
2015-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01210508. Inclusion in this directory is not an endorsement.