UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045011
Receipt number 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 2023/08/17 15:51:02

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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 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 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

Completed

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

2023 Year 08 Month 17 Day



Link to view the page

Value
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