Analysis of Tokuhashi Score

NCT01210508 | Terminated

• 1 other identifier: IRB 5797
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Metastases

Keywords

Cancer patients with metastases to the spinal column

Outcome Measures

Primary Outcomes (1)

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

  will follow subjects until death

  24 months

Secondary Outcomes (1)

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

  24 months

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in the Orthopedic Spine office, that have been diagnosed with metastases to the spine.

You may qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Cleveland Clinic Florida: collaborator

Study Sites (1)

Upstate Orthopedic Bone and Joint Center

East Syracuse, New York, 13057, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William F. Lavelle, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: September 28, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 25, 2015

Record last verified: 2013-09

Locations

US (1)