UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001175 |
|---|---|
| Receipt number | R000001439 |
| Scientific Title | analysis of immunocytes in patients with brain tumor treated with temozolomide |
| Date of disclosure of the study information | 2008/07/01 |
| Last modified on | 2010/06/04 18:39:59 |
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Basic information
Public title
analysis of immunocytes in patients with brain tumor treated with temozolomide
Acronym
analysis of immunocytes in patients with brain tumor treated with temozolomide
Scientific Title
analysis of immunocytes in patients with brain tumor treated with temozolomide
Scientific Title:Acronym
analysis of immunocytes in patients with brain tumor treated with temozolomide
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We analyze immunocytes, such as WT1 peptide specific CD8-positive killer T-cell, in patients with brain tumor treated with temozolomide and predict an effect when the WT1 peptide cancer immunotherapy is used together with radiotherapy and chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We collect blood from the patients before taking temozolomide, after 3 and 6 weeks after taking temozolomide, and every 4-8 weeks after that.
We extract the lymphocyte of the blood and analyze the immunocytes including WT1 peptide-specific CD8-positive killer T-cell.
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 with brain tumor treated with temozolomide
Key exclusion criteria
no
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Yoshmine |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
2-2 Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-3652
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiba Yasuyoshi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
TEL
06-6879-3652
Homepage URL
ychiba@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2008 | Year | 06 | Month | 04 | Day |
Last modified on
| 2010 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001439
