Analysis of Tokuhashi Score

NCT ID: NCT01210508

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-12-31

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

Conditions

Cancer; Metastases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cleveland Clinic Florida

OTHER

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

William Lavelle

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William F. Lavelle, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

Upstate Orthopedic Bone and Joint Center

East Syracuse, New York, United States

Countries

United States

Other Identifiers

IRB 5797

Identifier Type: -

Identifier Source: org_study_id