UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029381 |
|---|---|
| Receipt number | R000033578 |
| Scientific Title | The outcome and prognosis of neurological decompression and stabilization for spinal metastasis |
| Date of disclosure of the study information | 2017/10/15 |
| Last modified on | 2017/10/02 14:24:20 |
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Basic information
Public title
The outcome and prognosis of neurological decompression and stabilization for spinal metastasis
Acronym
The outcome and prognosis of neurological decompression and stabilization for spinal metastasis
Scientific Title
The outcome and prognosis of neurological decompression and stabilization for spinal metastasis
Scientific Title:Acronym
The outcome and prognosis of neurological decompression and stabilization for spinal metastasis
Region
| Japan |
Condition
Condition
spinal metastasis
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the Spinal Instability Neoplastic Score for predicting surgical outcomes and survival
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the Frankel score and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were compared between the two groups and patient survival was evaluated according to the SINS, Tokuhashi score, and Katagiri score.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
30 patients who underwent decompression and stabilization for spinal metastases at our institution between 2008 and 2016
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 47 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
30 patients who underwent decompression and stabilization for spinal metastases at our institution between 2008 and 2016
Key exclusion criteria
Follow up period less than 3 months after surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Masuda |
Organization
Yokosuka Kyosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-16 Yonegahama-dori, Yokosuka
TEL
046-822-2710
mashmash4952@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Masuda |
Organization
Yokosuka Kyosai Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-16 Yonegahama-dori, Yokosuka
TEL
046-822-2710
Homepage URL
mashmash4952@msn.com
Sponsor or person
Institute
Department of Orthopaedic Surgery
Yokosuka Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2017 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033578
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
