UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051394 |
|---|---|
| Receipt number | R000058629 |
| Scientific Title | Comprehensive exploration of gliomas in Osaka Medical and Pharmaceutical University |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/20 18:18:33 |
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Basic information
Public title
Comprehensive exploration of gliomas in Osaka Medical and Pharmaceutical University
Acronym
Comprehensive exploration of gliomas in Osaka Medical and Pharmaceutical University
Scientific Title
Comprehensive exploration of gliomas in Osaka Medical and Pharmaceutical University
Scientific Title:Acronym
Comprehensive exploration of gliomas in Osaka Medical and Pharmaceutical University
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Glioma is still intractable disease. However, novel therapies such as photodynamic therapy and tumor treating fields have been approved for malignant glioma. Boron neutron capture therapy (BNCT) is promising its effects on malignant glioma although BNCT is off-label for glioma. There is no standard role to use these novel therapies for patients with glioma. It is necessary to analyze treatment outcomes in our institute for promotion of personalized treatments in our institute. The aim of the present study is to elucidate outcome of each treatment and to form the foundation of tailor-made treatments for glioma in Osaka Medical and Pharmaceutical University.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival time
Key secondary outcomes
objective response rate
progression-free survival
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 were histologically or clinically diagnosed as glioma after 2000
Key exclusion criteria
Patients who was suspected, but not diagnosed as glioma
Patients whose clinical data was lost
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motomasa |
| Middle name | |
| Last name | Furuse |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Neurosurgery
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
motomasa.furuse@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Motomasa |
| Middle name | |
| Last name | Furuse |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Neurosurgery
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
+81-72-683-1221
Homepage URL
motomasa.furuse@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Institutional review board of Osaka Medical and Pharmaceutical University
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
Tel
0726831221
rinri@ompu.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
| 2023 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data of patients with glioma who were treated in our institute after 2000 are collected from clinical records. Pretreatment status, contents of treatments and prognosis are analyzed and appropriate treatment for each patient is elucidated. If patients are referred to other institutes, a questionnaire survey is conducted for patient status.
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058629
| 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 |
