UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023546 |
|---|---|
| Receipt number | R000027119 |
| Scientific Title | Exploration on the immunogenic gene mutation in human glioblastoma mutiforme by the next generation sequencer for establishment of therapeutic vaccine |
| Date of disclosure of the study information | 2016/08/09 |
| Last modified on | 2021/08/12 13:28:14 |
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Basic information
Public title
Exploration on the immunogenic gene mutation in human glioblastoma mutiforme by the next generation sequencer for establishment of therapeutic vaccine
Acronym
Exploration on immunogenic gene mutation in human glioblastoma multiforme
Scientific Title
Exploration on the immunogenic gene mutation in human glioblastoma mutiforme by the next generation sequencer for establishment of therapeutic vaccine
Scientific Title:Acronym
Exploration on immunogenic gene mutation in human glioblastoma multiforme
Region
| Japan |
Condition
Condition
Glioblastoma multiforme
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Using next generation sequencer,gene mutation exclusively expressed in long survivor but not in short survivor will be determined in glioblastoma mutiforme (GBM) patients treated with dendritic/tumor fusion vaccine for the prevention of GBM recurrence. New therapeutic vaccines might be generated based on the structural characteristics of the mutatnt antigenic peptides
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amino acid sequence of the mutated anigen commonly expressed in long survovors treated with the dendritic cell vaccine will be determined. Peptide vaccine will be designed based on the structure of the mutated antigen.
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Glioblastoma multiforme patients treated with dendritic/tumor cell fusion vaccine for prevention of recurrence whose tumor cells are stored for next generation sequencer analyses.
Key exclusion criteria
Glioblastoma multiforme patients treated with dendritic/tumor cell fusion vaccine for prevention of recurrence whose tumor cells are not stored for next generation sequencer analyses.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kamata |
Organization
Jikei University School of Medicine
Division name
Division of Oncology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
ykama@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kamata |
Organization
Jikei University School of Medicine
Division name
Division of Oncology
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
ykama@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
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
Jikei University IRB
Address
3-25-8 Nishi-shimbashi Minato-ku, Tokyo 105-8461,Japan
Tel
+81334331111
rinri@jikei.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
| 2016 | Year | 08 | Month | 09 | 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
20
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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Nothing in particular
Management information
Registered date
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027119
| 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 |
