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NCT01210508 · ClinicalTrials.gov registry record
Analysis of Tokuhashi Score
A clinical trial, sponsored by State University of New York - Upstate Medical University.
- Terminated
- Registry status
- 2
- Enrollment target
NCT01210508: Clinical Trial study, sponsored by State University of New York - Upstate Medical University.
NCT01210508 is a clinical trial that was terminated before completion, run by State University of New York - Upstate Medical University. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210508 was terminated before completion, sponsored by State University of New York - Upstate Medical University.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
will follow subjects until death
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-12 |
Why NCT01210508 stopped before completion
NCT01210508 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01210508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01210508 about?
NCT01210508 is a clinical study titled "Analysis of Tokuhashi Score". 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...
What is the current status of trial NCT01210508?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2009-03. Estimated completion is 2013-12.
Who is sponsoring clinical trial NCT01210508?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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