UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048749 |
|---|---|
| Receipt number | R000055517 |
| Scientific Title | Analytical Observational Study to Verify Reliability and Validity of Japanese Version-Oral Symptom Assessment Scale (OSAS) |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2026/02/17 20:14:34 |
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Basic information
Public title
Study to Verify Reliability and Validity of Japanese Version-Oral Symptom Assessment Scale (OSAS)
Acronym
Verification of Reliability and Validity of Japanese OSAS
Scientific Title
Analytical Observational Study to Verify Reliability and Validity of Japanese Version-Oral Symptom Assessment Scale (OSAS)
Scientific Title:Acronym
Verification of Reliability and Validity of Japanese OSAS
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify reliability and validity of Japanese OSAS.
Basic objectives2
Others
Basic objectives -Others
Analytical Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral symptom assessment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- 18 years old or above
- Patient with grade 3 to 4 malignant tumor
- Patient whose written consent to participate in the study obtained
Key exclusion criteria
- In case one cannot obtain consent to participate in the study
- In case one cannot answer the questionnaire
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Sena |
Organization
Tohoku University, Graduate of Dentistry
Division name
Division of Preventive dentistry/ Oral Supportive Care and Management
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi, JAPAN
TEL
022-717-8327
sena@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Sena |
Organization
Tohoku University, Graduate School of Dentistry
Division name
Division of Preventive dentistry/ Oral Supportive Care and Management
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi, JAPAN
TEL
022-717-8327
Homepage URL
sena@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Miyagi, JAPAN
Tel
022-717-8244
ec-dent@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | 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
100
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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Survey response required
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055517
