UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022789 |
|---|---|
| Receipt number | R000026235 |
| Scientific Title | Evaluation of kinds of taste damaged by cord blood cell transplantation |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/10/08 16:34:10 |
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Basic information
Public title
Evaluation of kinds of taste damaged by cord blood cell transplantation
Acronym
Evaluation of kinds of taste damaged by cord blood cell transplantation
Scientific Title
Evaluation of kinds of taste damaged by cord blood cell transplantation
Scientific Title:Acronym
Evaluation of kinds of taste damaged by cord blood cell transplantation
Region
| Japan |
Condition
Condition
hematologic malignancies before hematopoietic stem cell transplantion
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of kinds of taste damaged by cord blood cell transplantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste perception before and 4 weeks after hematopoietic stem cell transplantation
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
definition of kinds of taste using by paper filters
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who are going to take cord blood stem cell transplantation
Key exclusion criteria
Those who've got chemotherapy or stem cell transplantation before.
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
Dentistry
Zip code
105-0001
Address
2-2-2, Toranomon, Minato-Ku, Tokyo
TEL
0335881111
m.mizutani@toranomon.gr.jp
Public contact
Name of contact person
| 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
0335881111
Homepage URL
m.mizutani@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
Organization
Division
Category of Funding Organization
Other
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
0335881111
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
| 2016 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 08 | 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
| 2016 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
