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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045011
Receipt No. R000051314
Scientific Title A research about evaluating methodology of cell function characteristics, employing a newly developed flow cytometric technology
Date of disclosure of the study information 2022/08/04
Last modified on 2022/08/05

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Basic information
Public title A research about evaluating methodology of cell function characteristics, employing a newly developed flow cytometric technology
Acronym A research about evaluating methodology of cell function characteristics, employing a newly developed flow cytometric technology
Scientific Title A research about evaluating methodology of cell function characteristics, employing a newly developed flow cytometric technology
Scientific Title:Acronym A research about evaluating methodology of cell function characteristics, employing 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 In order to verify a methodology for evaluating cell characteristics such as blood-cell form, function, type, etc., employing a newly developed flow cytometric technology
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 subjects ranging in age from 20 to 59, at informed consent.
(2) Subjects 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) Subjects being under some kind of continuous medical treatment, except applying a nasal spray and eye drops.
(2) Subjects who took a steroid within the last three months from the time point of clinic visiting.
(3) Subjects who apply a steroid all the year around, except a seasonal use and deteriorating conditions.
(4) Subjects who were vaccinated against some kind of disease within the past two weeks to the clinic visiting.
(5) Pregnant, possibly pregnant, and lactating women.
(6) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(7) Subjects touching excessive alcohol.
(8) Subjects with serious drug and/or food allergy.
(9) Subjects who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after this research, or are planning to join those after giving informed consent to participate in this research.
(10) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this research.
(11) Males who donated their whole blood (400 mL) within the last three months to this research.
(12) Females who donated their whole blood (400 mL) within the last four months to this research.
(13) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research.
(14) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research.
(15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Wagatsuma
Organization ThinkCyte, Inc
Division name Senior Scientist
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-3868-2520
Email kwagatsuma@thinkcyte.com

Public contact
Name of contact person
1st name Mitsuhiro
Middle name
Last name Fujimoto
Organization CPCC Company Limited
Division name Clinical Planning Department
Zip code 101-0047
Address 4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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 Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email 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
2022 Year 08 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
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 Open public recruiting
Date of protocol fixation
2021 Year 07 Month 20 Day
Date of IRB
2021 Year 07 Month 16 Day
Anticipated trial start date
2021 Year 08 Month 04 Day
Last follow-up date
2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This research is conducted to verify whether a newly developed flow cytometric technology equipped with possible imaging analysis can evaluate cell characteristics such as blood-cell form, function, type, and so on.

Management information
Registered date
2021 Year 07 Month 30 Day
Last modified on
2022 Year 08 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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