UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051747 |
|---|---|
| Receipt number | R000058915 |
| Scientific Title | Analysis of Recurrence-Free Survival after Preoperative Embolization and Surgical Resection for Meningiomas (Multi-Center Observational Study) |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/11/01 20:21:59 |
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Basic information
Public title
Analysis of Recurrence-Free Survival after Preoperative Embolization and Surgical Resection for Meningiomas (Multi-Center Observational Study)
Acronym
Analysis of Recurrence-Free Survival after Preoperative Embolization and Surgical Resection for Meningiomas (Multi-Center Observational Study)
Scientific Title
Analysis of Recurrence-Free Survival after Preoperative Embolization and Surgical Resection for Meningiomas (Multi-Center Observational Study)
Scientific Title:Acronym
Analysis of Recurrence-Free Survival after Preoperative Embolization and Surgical Resection for Meningiomas (Multi-Center Observational Study)
Region
| Japan |
Condition
Condition
Intracranial meningiomas
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether preoperative embolization for meningiomas has a suppressive or accelerative effect on recurrence after resection. Specifically, we will compare two groups: cases where meningioma resection was performed alone and cases where resection was performed after preoperative embolization. We will analyze the impact of preoperative embolization on recurrence using time-series data such as images obtained during the postoperative follow-up period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of recurrence-free survival after surgical resection between cases with and without preoperative embolization for meningiomas
Key secondary outcomes
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 who underwent meningioma resection at the Department of Neurosurgery, Tokyo Metropolitan Tama Medical Center and collaborating research institutions from April 2011 to March 2023.
Key exclusion criteria
The following patient groups are excluded:
- Patients referred after surgery at other hospitals for recurrent cases.
- Patients without postoperative imaging follow-up.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ota |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Neurosurgery
Zip code
183-8524
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
TEL
042-323-5111
takaota@tama-mail.jp
Public contact
Name of contact person
| 1st name | Daiichiro |
| Middle name | |
| Last name | Ishigami |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Neurosurgery
Zip code
183-8524
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
dishigami-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Ethics Committee of Tokyo Metropolitan Tama Medical Center
Address
Musashidai 2-8-29, Fuchu-shi, Tokyo
Tel
042-323-5111
nanako_abe@tmhp.jp
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
東京都立多摩総合医療センター（東京都），東京大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age and sex at the time of meningioma resection, past medical history, family history; radiographic features of the meningiomas; whether preoperative embolization was performed in each case, vessels embolized and embolic agents used, penetration of the embolic agent into the tumor vasculature, the extent of resection based on Simpson grade; pathological findings and classification of the meningiomas
Management information
Registered date
| 2023 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058915
