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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026813
Receipt No. R000030783
Scientific Title Research of Smell Disorder in Unrelated Stem Cell Transplantation
Date of disclosure of the study information 2017/04/11
Last modified on 2019/10/08

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Basic information
Public title Research of Smell Disorder in Unrelated Stem Cell Transplantation
Acronym Smell Disorder
Scientific Title Research of Smell Disorder in Unrelated Stem Cell Transplantation
Scientific Title:Acronym Smell Disorder
Region
Japan

Condition
Condition Patients who are going to receive unrelated stem cell transplantation
Classification by specialty
Hematology and clinical oncology Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Research of smell disorder in unrelated stem cell transplantation
Basic objectives2 Others
Basic objectives -Others taste disorder
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Before and after of unrelated stem cell transplantation
Key secondary outcomes Before and after of unrelated stem cell transplantation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Test of smell
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who are going to receive their first time unrelated stem cell transplantation
Key exclusion criteria Those who have already received unrelated stem cell transplantaion and children
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Mieko
Middle name
Last name Mizutani
Organization Toranomon Hospital
Division name Division of Dentistry
Zip code 105-0001
Address 2-2-2, Toranomon, Minato-Ku, Tokyo
TEL 03-3588-1111
Email m.mizutani@toranomon.gr.jp

Public contact
Name of contact person
1st name Mieko
Middle name
Last name Mizutani
Organization Toranomon Hosipital
Division name Division of Dentistry
Zip code 105-0001
Address 2-2-2, Toranomon, Minato-Ku, Tokyo
TEL 03-3588-1111
Homepage URL
Email m.mizutani@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital Division of Dentistry
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Toranomon Hospital
Address 2-2-2 Toranomon Minato-ku
Tel 03-3588-1111
Email m.mizutani@toranomon.gr.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
2017 Year 04 Month 11 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 Completed
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
2017 Year 08 Month 18 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 31 Day
Last modified on
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030783

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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