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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001175
Receipt No. 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

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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
Email

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
Email ychiba@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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