UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063150 |
|---|---|
| Receipt number | R000072279 |
| Scientific Title | Validation of sample processing and transport conditions for establishing standard operating procedures (SOPs) for blood component evaluation |
| Date of disclosure of the study information | 2026/10/12 |
| Last modified on | 2026/10/02 13:37:46 |
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Basic information
Public title
Validation of blood preservation and transport conditions for standardizing blood component evaluation
Acronym
Blood Component Standardization Study
Scientific Title
Validation of sample processing and transport conditions for establishing standard operating procedures (SOPs) for blood component evaluation
Scientific Title:Acronym
Blood Sample SOP Study
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of sample processing and transport conditions on sample quality and analytical results in circulating microRNA analysis, and to establish practical standard operating procedures (SOPs).
Basic objectives2
Others
Basic objectives -Others
Evaluation of pre-analytical factors affecting circulating microRNA analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Circulating microRNA expression profiles assessed by next-generation sequencing (NGS) and real-time PCR
Key secondary outcomes
Sample quality and hemolysis indicators assessed by visual inspection and molecular biomarkers
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy males and females aged 20 years or older and under 70 years at the time of informed consent
2.Individuals who voluntarily wish to participate in the study and are able to provide written informed consent
3.Individuals who have received a full explanation of the study, understand its content, and have provided written informed consent
Key exclusion criteria
1. Individuals with a current history of severe cardiac, hepatic, renal, or gastrointestinal disease, or who have been advised by a physician to undergo medical treatment based on health checkup results within the past year
2. Individuals with a current history or suspicion of anemia (abnormal hemoglobin levels)
3. Individuals with a history of vasovagal response (vasovagal syncope) during blood sampling
4. Male individuals who have donated 400 mL of whole blood within 3 months prior to the start of this study
5. Female individuals who have donated 400 mL of whole blood within 4 months prior to the start of this study
6. Individuals who tested positive or are suspected positive in infectious disease screening tests (HBs antigen, HCV 3rd generation antibody, syphilis TP antibody, HIV 1/2 antigen/antibody)
7. Other individuals deemed unsuitable for participation in the study by the principal investigator
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kono |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawa Kewport, Sengawa-cho, Chofu-Shi, Tokyo, Japan
TEL
03-5384-7759
yoshinori_kono@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Sakai |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawa Kewport, Sengawa-cho, Chofu-Shi, Tokyo, Japan
TEL
03-5384-7759
Homepage URL
yumi_sakai@kewpie.co.jp
Sponsor or person
Institute
Kewpie corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Tokyo Haneda Watanabe Clinic Ethical Review Committee, Medical Corporation Shaeikai
Address
1-5-16 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
r.k@kanamori.co.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
医療法人社団東山会 東山ドック・健診クリニック ウェルピアザ仙川（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 12 | 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
| 2026 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 24 | 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
This is an observational study to evaluate sample processing, storage, and transport conditions for establishing standard operating procedures (SOPs) for blood component evaluation.
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072279
