UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054179 |
|---|---|
| Receipt number | R000061867 |
| Scientific Title | Exploratory study to investigate factors affecting urinary 8-OHdG and diacetylspermine measured by miSignal Check/miSignal Lite |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/17 15:38:29 |
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Basic information
Public title
Exploratory study to investigate factors affecting urinary 8-OHdG and diacetylspermine measured by miSignal Check/miSignal Lite
Acronym
Exploratory study to investigate factors affecting urinary 8-OHdG and diacetylspermine measured by miSignal Check/miSignal Lite
Scientific Title
Exploratory study to investigate factors affecting urinary 8-OHdG and diacetylspermine measured by miSignal Check/miSignal Lite
Scientific Title:Acronym
Exploratory study to investigate factors affecting urinary 8-OHdG and diacetylspermine measured by miSignal Check/miSignal Lite
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the relationship measurements of urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG)/N1, N12-Diacetylspermine and demographic characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of urinary concentrations of 8-OHdG and DiAcSpm (creatinine-adjusted) obtained from participants of MySignal Check/MySignal Lite with demographic information.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1) Obtained consent to participate in this study when applying for miSignal Check/miSignal Lite
2) The age of 18 years and above
Key exclusion criteria
Subjects whom the principal investigator evaluates unsuitable to participate in this study
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ichikawa |
Organization
Craif Inc.
Division name
Chief Technology Officer
Zip code
113-0034
Address
5F Hongo ITP Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
clinicaltrial@craif.com
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Mikami |
Organization
Craif inc.
Division name
Clinical Development
Zip code
113-0034
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
Self funded
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Craif Institutional Review Board
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
Tel
03-6801-8334
clinicaltrial@craif.com
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
| 2024 | Year | 04 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | 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=R000061867
