UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057649 |
|---|---|
| Receipt number | R000065583 |
| Scientific Title | A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology |
| Date of disclosure of the study information | 2026/04/18 |
| Last modified on | 2025/04/04 18:39:07 |
* 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
A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology
Acronym
A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology
Scientific Title
A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology
Scientific Title:Acronym
A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the methodology for assessing cell morphology, function, classification, and other cellular characteristics using a newly developed flow cytometric technology capable of acquiring cell morphological information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Counts of white blood cell, red blood cell, and platelet
Key secondary outcomes
Examinations of blood cell - -
(1) expressing protein (conventional/ghost flow cytometry),
(2) form (conventional/ghost flow cytometry, and microscopic observation),
(3) proliferation (general cell counting, or conventional/ghost flow cytometry),
(4) differentiation induction (conventional/ghost flow cytometry, microscopic observation, reverse transcription-polymerase chain reaction, and ribonucleic acid-sequencing),
(5) function (conventional/ghost flow cytometry),
(6) secretary protein (enzyme-linked immunosorbent assay),
(7) drug response (conventional/ghost flow cytometry, microscopic observation, reverse transcription-polymerase chain reaction, and ribonucleic acid-sequencing),
(8) gene expression (reverse transcription-polymerase chain reaction, and ribonucleic acid sequencing),
(9) gene function (conventional/ghost flow cytometry, reverse transcription-polymerase chain reaction, and ribonucleic acid-sequencing) - - .
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female Individuals ranging in age from 20 to 59, at informed consent.
(2) Individuals who can give informed consent to take part in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Individuals being under some kind of continuous medical treatment, except applying a nasal spray and eye drops.
(2) Individuals who took a steroid within the last three months from the time point of clinic visiting.
(3) Individuals who apply a steroid all the year around, except a seasonal use and deteriorating conditions.
(4) Individuals who were vaccinated within the past two weeks to the clinic visiting.
(5) Individuals touching excessive alcohol.
(6) Individuals with serious drug and/or food allergy.
(7) Individuals who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after this research.
(8) Individuals with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(9) Females who are pregnant or lactating.
(10) Individuals who donated 200 mL of their blood or blood components within the last month.
(11) Individuals who donated 400 mL of his blood within the last 3 months.
(12) Individuals who donated 400 mL of her blood within the last 4 months.
(13) Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
(14) Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
(15) Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Wagatsuma |
Organization
ThinkCyte, Inc
Division name
Research & Development
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3868-2520
kwagatsuma@thinkcyte.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
ThinkCyte, Inc
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 18 | 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
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate methods for assessing the morphology, function, type, and other characteristics of blood cells using a novel flow cytometry technology capable of capturing morphological information.
Management information
Registered date
| 2025 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065583
