CancerNCT01210508
Analysis of Tokuhashi Score
An observational study of Cancer and Metastases, run by State University of New York - Upstate Medical University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cancer, Metastases
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen in the Orthopedic Spine office, that have been diagnosed with metastases to the spine.
Who may be able to join
- 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
Who cannot join
- There is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Orthopedic Bone and Joint Center
East Syracuse, New York, 13057
About this study
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
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.
Read 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.
Read the detailed description
all info is in brief summary
- Conditions
- Cancer, Metastases
- Keywords
- Cancer patients with metastases to the spinal column
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases
will follow subjects until death
Measured: 24 months
Secondary outcomes (1)
the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score
will follow subjects until death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cleveland Clinic Florida
- Responsible party
- Principal investigator, William Lavelle, State University of New York - Upstate Medical University
- Investigators
- William F. Lavelle, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210508
- Sponsor's protocol ID
- IRB 5797
- Status last verified
- Sep 2013
- First submitted
- 26 Jan 2010
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01210508
- Acronym / sponsor ID
- IRB 5797
- Conditions
- Cancer, Metastases
- Keywords
- Cancer patients with metastases to the spinal column
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Cleveland Clinic Florida
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen in the Orthopedic Spine office, that have been diagnosed with metastases to the spine.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- There is no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases
Time frame: 24 months
will follow subjects until death
1 secondary outcome
the relationship of treatment on survival after detecting spinal metastases in relation to the Tokuhashi score
Time frame: 24 months
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William F. Lavelle, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastases, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Tokuhashi score's validity in predicting survival after developing spinal metastases (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.