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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041110
Receipt No. R000046948
Scientific Title Observational study on the analyzing transferability of drugs and androgens to the central nervous system using human brain tissue
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/15

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Basic information
Public title Observational study on the analyzing transferability of drugs and androgens to the central nervous system using human brain tissue
Acronym Analyzing transferability of drugs and androgens to the central nervous system
Scientific Title Observational study on the analyzing transferability of drugs and androgens to the central nervous system using human brain tissue
Scientific Title:Acronym Analyzing transferability of drugs and androgens to the central nervous system
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the transferability of drugs and androgens to the central nervous system by genetic polymorphism of P-glycoprotein
Basic objectives2 Others
Basic objectives -Others Relationship analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the relationship between single nucleotide polymorphisms of P-glycoprotein and human brain tissue concentrations of drugs and androgens
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 Samples stored in the Brain Bank at the Mihara Memorial Hospital
Key exclusion criteria Inappropriate as a subject by a responsible person
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takuo
Middle name
Last name Ogihara
Organization Takasaki University of Health and Welfare
Division name Graduate School of Pharmaceutical Sciences
Zip code 370-0033
Address 60 Nakaorui-machi, Takasaki, Gunma, Japan
TEL 027-352-1180
Email togihara@takasaki-u.ac.jp

Public contact
Name of contact person
1st name Takuo
Middle name
Last name Ogihara
Organization Takasaki University of Health and Welfare
Division name Graduate School of Pharmaceutical Sciences
Zip code 370-0033
Address 60 Nakaorui-machi, Takasaki, Gunma, Japan
TEL 027-352-1180
Homepage URL
Email togihara@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Brain and Blood Vessels Mihara Memorial Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Review Committee of Takasaki University of Health and Welfare
Address 37-1 Nakaorui-machi, Takasaki, Gunma, Japan
Tel 027-352-1290
Email kuwabara@takasaki-u.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 高崎健康福祉大学(群馬県)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 26 Day
Date of IRB
2020 Year 03 Month 10 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is an observational study that evaluates the relationship between single nucleotide polymorphisms in P-glycoprotein and drug and androgen concentrations in human brain tissue.

Management information
Registered date
2020 Year 07 Month 15 Day
Last modified on
2020 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046948

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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