UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030170 |
|---|---|
| Receipt number | R000034460 |
| Scientific Title | Prospective cohort study of standard therapy for primary malignant brain tumor patient |
| Date of disclosure of the study information | 2017/11/29 |
| Last modified on | 2023/12/12 11:27:02 |
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Basic information
Public title
Prospective cohort study of standard therapy for primary malignant brain tumor patient
Acronym
Prospective cohort study of standard therapy for primary malignant brain tumor patient
Scientific Title
Prospective cohort study of standard therapy for primary malignant brain tumor patient
Scientific Title:Acronym
Prospective cohort study of standard therapy for primary malignant brain tumor patient
Region
| Japan |
Condition
Condition
primary malignant brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment outcome of standard therapy for primary malignant brain tumor patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
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
Patient who underwent craniotomy
Extent of resection was total/subtoal
Patient who will undergo standard postoperative adjuvant chemoradiotherapy
Key exclusion criteria
Patient who underwent PDT
Patient who will undergo non-standard therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Kuroiwa |
Organization
Tesseikai Neurosurgical Hospital
Division name
Department of Neurosurgery
Zip code
575-8511
Address
28-1 Nakanohommachi, Shijonawate, Osaka, Japan
TEL
072-877-6639
toshihiko.kuroiwa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tsuzuki |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
162-8666
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo, Japan
TEL
03-3353-8112(28283)
Homepage URL
tsuzuki.shunsuke@twmu.ac.jp
Sponsor or person
Institute
Japan Photodynamic Neurosurgical Society
Institute
Department
Personal name
Funding Source
Organization
Meiji Seika Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Institutional Review Board
Address
8-1 Kawada-cho, Shinuku-ku, Tokyo, Japan
Tel
03-3353-8111
rinri.bm@twmu.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 29 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the treatment outcome of standard therapy for primary malignant brain tumor patient
Management information
Registered date
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034460
| 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 |
