Analysis of Tokuhashi Score

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01210508
• Other study ID #: IRB 5797
• Status: Terminated
• Phase: N/A
• First received: January 26, 2010
• Last updated: May 22, 2015
• Start date: March 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

all info is in brief summary

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
United States	Upstate Orthopedic Bone and Joint Center	East Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases	will follow subjects until death	24 months	No
Secondary	the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score	will follow subjects until death	24 months	No