- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934594
Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
October 13, 2016 updated by: National Taiwan University Hospital
Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy.
Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B).
The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2).
All patients underwent palliative decompression and posterior stabilization.
Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine.
Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shu-Hua Yang, M.D., Ph.D.
- Phone Number: 63981 886-2-23123456
- Email: 005964@ntuh.gov.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.
Description
Inclusion Criteria:
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.
Exclusion Criteria:
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
Motor function intact group: received palliative decompression
|
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
|
Group B1
motor deficit group: received palliative decompression within 48 hours after symptoms occured
|
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
|
Group B2
motor deficit group: received palliative decompression 48 hours after symptoms occured
|
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival rate
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Shu-Hua Yang, M.D., Ph.D., National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.
- Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (ANTICIPATED)
August 1, 2020
Study Completion (ANTICIPATED)
August 1, 2020
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (ESTIMATE)
October 17, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
October 17, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201608007RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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