UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054457 |
|---|---|
| Receipt number | R000062197 |
| Scientific Title | Assessment of Oral Paresthesia after Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2024/11/21 09:27:49 |
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Basic information
Public title
Assessment of Oral Paresthesia after Hematopoietic Stem Cell Transplantation
Acronym
Assessment of Oral Paresthesia after Hematopoietic Stem Cell Transplantation
Scientific Title
Assessment of Oral Paresthesia after Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
Assessment of Oral Paresthesia after Hematopoietic Stem Cell Transplantation
Region
| Japan |
Condition
Condition
Patients after hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess oral paresthesia after hematopoietic stem cell transplantation by questionnaire.
Basic objectives2
Others
Basic objectives -Others
Assessment of oral paresthesia after hematopoietic stem cell transplantation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency and kinds of oral paresthesia, and factors of each symptoms.
Key secondary outcomes
Assessment of hyposalivation
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Assessment of hyposalivation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who underwent hepatopoietic stem cell transplantaiton at Toranomon Hospital and who see dentist regularly.
Key exclusion criteria
Patients who underwent autologous stem cell transplantation, patients whose age are under 18, and who do not see a dentist at Toranomon Hospital.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mieko |
| Middle name | |
| Last name | Mizutani |
Organization
Toranomon Hospital
Division name
Department of Dentistry
Zip code
105-8470
Address
2-2-2 Toranomon Minato-ku, Tokyo
TEL
03-3588-1111
m.mizutani@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Mieko |
| Middle name | |
| Last name | Mizutani |
Organization
Toranomon Hospital
Division name
Department of Dentistry
Zip code
105-0001
Address
2-2-2 Toranomon Minato-ku, Tokyo
TEL
0335881111
Homepage URL
https://toranomon.kkr.or.jp/
m.mizutani@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Mieko Mizutani
Funding Source
Organization
Not applicable
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, Tokyo
Tel
03-3588-1111
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
虎の門病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062197
