UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007660 |
|---|---|
| Receipt number | R000008988 |
| Scientific Title | Therapeutic strategy and long-term outcome of meningiomas located in posterior cranial fossa |
| Date of disclosure of the study information | 2012/04/04 |
| Last modified on | 2015/10/04 09:33:21 |
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Basic information
Public title
Therapeutic strategy and long-term outcome of meningiomas located in posterior cranial fossa
Acronym
meningiomas of posterior cranial fossa
Scientific Title
Therapeutic strategy and long-term outcome of meningiomas located in posterior cranial fossa
Scientific Title:Acronym
meningiomas of posterior cranial fossa
Region
| Japan |
Condition
Condition
posterior cranial fossa meningioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
development of surgical approach
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
KPS
Key secondary outcomes
GCS
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
selection of surgical approach
Interventions/Control_2
preoperative simulation surgery
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
posterior cranial fossa tumor
meningioma
symptomatic
Key exclusion criteria
aging
harboring malignancy
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Matsui |
Organization
Saitama Medical Center/Kawagoe Campus/Saitama Medical University
Division name
Department of Neurosurgery
Zip code
Address
1981 Kamota, Kawagoe, Saitama, Japan
TEL
049-228-3712
matsui@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Matsui |
Organization
Saitama Medical Center/Kawagoe Campus/Saitama Medical University
Division name
Department of Neurosurgery
Zip code
Address
1981 Kamota, Kawagoe, Saitama, Japan
TEL
049-228-3712
Homepage URL
http://www.saitama-med.ac.jp/kawagoe/index.html
matsui@saitama-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Saitama Medical Center/Kawagoe Campus/Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center/Kawagoe Campus/Saitama Medical University
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
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008988
