UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052990 |
|---|---|
| Receipt number | R000060457 |
| Scientific Title | Exploratory study on the correlation between urinary biomarkers and oral function, and behavioral changes based on return of test results |
| Date of disclosure of the study information | 2023/12/04 |
| Last modified on | 2024/04/17 09:53:23 |
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Basic information
Public title
Exploratory study on the correlation between urinary biomarkers and oral function, and behavioral changes based on return of test results
Acronym
Exploratory study on the correlation between urinary biomarkers and oral function, and behavioral changes based on return of test results
Scientific Title
Exploratory study on the correlation between urinary biomarkers and oral function, and behavioral changes based on return of test results
Scientific Title:Acronym
Exploratory study on the correlation between urinary biomarkers and oral function, and behavioral changes based on return of test results
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the correlation between urinary biomarkers and the oral environment in women in their 40s and 50s. In addition, evaluate the effect of returning test results on behavioral changes in lifestyle habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary biomarkers and oral indicators
Health questionnaire and VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
View test results
Interventions/Control_2
No intervention
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Women who are 40 years old or more and under 60 years old
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
3.Persons who were judged as inappropriate for study participants by the principal investigator
4.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Shimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
shimura.mari@hc-sys.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Shimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
shimura.mari@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kurume Leading Project
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
0368092722
soumu@hc-sys.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 | 12 | 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
20
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
| 2023 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060457
