UMIN-CTR Clinical Trial

Basic information
Public title	In charity live participants Survey on donation behavior and testosterone levels
Acronym	Donation behavior survey
Scientific Title	In charity live participants Survey on donation behavior and testosterone levels
Scientific Title:Acronym	Donation behavior survey
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.Investigate whether participation in charity live will change donation behavior. 2.Investigate the effects of participation in charity live on testosterone levels. 3.Examine the relationship between the two.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Changing awareness about donations before and after participating in the concert 2.Change in testosterone level before and after participating in the live performance 3.Correlation between 1 and 2
Key secondary outcomes	None

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	12 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Remember Girl's Power participant 2.Participant with consent
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Hamasaki
Organization	3H Clinical Trial Inc.
Division name	LIFTA for Oncology
Zip code	171-0022
Address	Ikebukuro YS Bldg.2F,1-13-23 Minami-Ikebukuro Toshima-ku
TEL	03-5928-0991
Email	hamasaki@3h-ct.co.jp

Public contact
Name of contact person	1st name Anri Middle name Last name Watanabe
Organization	3H Clinical Trial Inc.
Division name	LIFTA for Oncology
Zip code	171-0022
Address	Ikebukuro YS Bldg.2F,1-13-23 Minami-Ikebukuro Toshima-ku
TEL	03-5928-0991
Homepage URL
Email	a-watanabe@3h-ct.co.jp

Sponsor
Institute	3H Clinical Trial Inc. LIFTA for Oncology
Institute
Department

Funding Source
Organization	3H Clinical Trial Inc. LIFTA for Oncology
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	M
Name of secondary funder(s)

IRB Contact (For public release)
Organization	JCCR
Address	Ikebukuro Ichigo Bldg.2F,2-27-17 Minami-Ikebukuro Toshima-ku
Tel	03-6868-7022
Email	a-a@a

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	2019 Year 08 Month 30 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	2019 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 08 Month 30 Day
Last modified on	2019 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043166