UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001989 |
|---|---|
| Receipt number | R000002425 |
| Scientific Title | Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis. |
| Date of disclosure of the study information | 2009/05/21 |
| Last modified on | 2009/05/21 09:23:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Acronym
Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Scientific Title
Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Scientific Title:Acronym
Difference of extradural expansion between vertebral bone metastasis and abscess of pyogenic spondylarthritis.
Region
| Japan |
Condition
Condition
vertebral bone metasitasis,
pyogenic spondylarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the difference of extradural expansoin between vertebral bone metastasis and pyogenic spondylarthritis, using MRI.
Basic objectives2
Others
Basic objectives -Others
To evaluate extradural expansion forms and compression type of dura mater in MRI.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Using MRI, for example, sagital and axail view of T1 and T2 intensity, estimate
extradural expansion of metastasis and infection.
Key secondary outcomes
To estimate MRI of spine, when taking at severe clinical symptoms.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients of vertebral bone metastasis, or pyogenic infection of spine.
Key exclusion criteria
Exclusion of primary bone tumor, and spondylarthritis without pyogenic infection.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Imabayashi |
Organization
National diffence of medical collage
Division name
Orthopedic
Zip code
Address
Namiki 3-2, Tokorozawa City, Saitama prefecture
TEL
04-2995-1663
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Imabayashi |
Organization
National Diffence of medical collage
Division name
Orthopedic
Zip code
Address
Namiki 3-2, Tokorozawa City, Saitama Prefecture
TEL
04-2995-1211
Homepage URL
hidk693@ndmc.ac.jp
Sponsor or person
Institute
National Diffence of Medical Collage
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2009 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of extradural expansion of vertebral metastasis, pyogenic infection of spine. That are supposed to relate clinical findings,especially progressing paralysis.
Management information
Registered date
| 2009 | Year | 05 | Month | 21 | Day |
Last modified on
| 2009 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002425
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
