UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052098 |
|---|---|
| Receipt number | R000059330 |
| Scientific Title | Study to Validate an Oral Assessment Tool Suitable for Palliative Care Patients |
| Date of disclosure of the study information | 2023/09/04 |
| Last modified on | 2023/09/04 10:49:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study to Validate an Oral Assessment Tool Suitable for Palliative Care Patients
Acronym
MIMA-study
Scientific Title
Study to Validate an Oral Assessment Tool Suitable for Palliative Care Patients
Scientific Title:Acronym
MIMA-study
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate which of the OAG and OHAT is more suitable as an oral assessment tool for palliative care patients.
Basic objectives2
Others
Basic objectives -Others
Examine risk factors for each item of OAG and OHAT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Date of death
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients admitted to our medical center between March 2021 and March 2023.
(2)Patients diagnosed with terminal cancer.
(3)Patients treated by the palliative care team.
(4)Patients who have given oral and written informed consent for dental intervention.
Key exclusion criteria
Patients receiving chemotherapy for life extension.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mifumi |
| Middle name | |
| Last name | Nakao |
Organization
National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan
Division name
Department of Oral and Maxillofacial Surgery
Zip code
860-0008
Address
1-5, ninomaru, tyuuouku, kumamoto-city, kumamoto prefecture
TEL
0963536501
nakao.mifumi.qk@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Mifumi |
| Middle name | |
| Last name | Nakao |
Organization
National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan
Division name
Department of Oral and Maxillofacial Surgery
Zip code
860-0008
Address
1-5, ninomaru, tyuuouku, kumamoto-city, kumamoto prefecture
TEL
0963536501
Homepage URL
nakao.mifumi.qk@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan
Institute
Department
Personal name
Funding Source
Organization
nothing
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
National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan
Address
1-5, ninomaru, tyuuouku, kumamoto-city, kumamoto prefecture
Tel
0963536501
nakao.mifumi.qk@mail.hosp.go.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
| 2023 | Year | 09 | Month | 04 | 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
116
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted a retrospective observational study on palliative care patients at our hospital from March 2021 to March 2023. Oral health status was assessed using the OAG and OHAT. The collected data were validated using statistical methods, such as time-dependent ROC curve analysis.
Management information
Registered date
| 2023 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059330
