UMIN-ICDS Clinical Trial

Public title

Evaluation of the validity of the self-blood collection method using a microsampling device and comparison of the clinical laboratory test values with the blood collection method by venipuncture.

Acronym

Evaluation of the validity of the self-blood collection method using a microsampling device and comparison of the clinical laboratory test values with the blood collection method by venipuncture.

Scientific Title

Evaluation of the validity of the self-blood collection method using a microsampling device and comparison of the clinical laboratory test values with the blood collection method by venipuncture.

Scientific Title:Acronym

Evaluation of the validity of the self-blood collection method using a microsampling device and comparison of the clinical laboratory test values with the blood collection method by venipuncture.

Region

Japan

Condition

Diseases requiring blood collection for clinical laboratory tests.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the validity of the blood collection method using the Tasso Mini and of the clinical laboratory tests performed on the collected specimens.

Basic objectives2

Others

Basic objectives -Others

Performance evaluation of medical devices

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Comparison of clinical laboratory test values in blood collected using the Tasso Mini and by venipuncture.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Blood samples are collected using Tasso Mini.

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

[Common]
1.Individuals who have understood the content of this study and have voluntarily consented to participate.
2.Individuals who are able to undergo blood collection by venipuncture from the forearm and by using the Tasso Mini from the upper arm.
3.Individuals who do not have any chronic diseases, or who have chronic diseases with stable symptoms (excluding individuals with diseases listed in the exclusion criteria).
4.Individuals who were born in Japan, whose parents are Japanese, and whose maternal and paternal grandparents are also Japanese.
[Group A: Healthy adults aged 18 to 40 years]
5.Healthy Japanese aged 18 to 40 years, inclusive, at the time of consent.
6.Individuals with a Body Mass Index (BMI) [weight (kg) / (height [m])^2] of 18.5 kg/m^2 to less than 25.0 kg/m^2 at the screening examination.
[Group B: Healthy Japanese males aged 65 years or older]
7.Healthy Japanese males aged 65 years or older at the time of consent.
8.Individuals with a BMI [weight (kg) / (height [m])^2] of 18.5 kg/m^2 to less than 25.0 kg/m^2 at the screening examination.
[Group C: Healthy adults with a BMI of less than 18.5]
9.Healthy Japanese aged 18 to 40 years, inclusive, at the time of consent.
10.Individuals with a BMI [weight (kg) / (height [m])^2] of less than 18.5 kg/m^2 at the screening examination.
[Group D: Healthy adults with a BMI of 27.5 or higher]
11.Healthy Japanese aged 18 to 40 years, inclusive, at the time of consent.
12.Individuals with a BMI [weight (kg) / (height [m])^2] of 27.5 kg/m^2 or higher at the screening examination.
13.Individuals with a subcutaneous fat thickness of the upper arm (caliper method) of 14.0 mm or greater for males and 20.0 mm or greater for females.
[Group E: Healthy postmenopausal adult females aged 65 years or older]
14.Healthy postmenopausal Japanese females aged 65 years or older at the time of consent.
15.Individuals with a BMI [weight (kg) / (height [m])^2] of 18.5 kg/m^2 to less than 25.0 kg/m^2 at the screening examination.

Key exclusion criteria

1.Subjects who have withdrawn their consent after initially providing it voluntarily.
2.Individuals with cardiovascular or hematological diseases, or those with a history of these diseases and recognized impairment of cardiopulmonary function.
3.Individuals with diseases that damage blood vessels, such as cancer, diabetes mellitus, or collagen diseases, or with a history of these diseases.
4.Individuals for whom blood collection from the upper arm is difficult due to skin problems such as infection, inflammation, extensive scarring, or skin damage.
5.Individuals with serious diseases or abnormalities that would interfere with safe participation in or conduct of the study (as judged by the principal investigator).
6.Individuals taking anticoagulants.
7.Individuals with an acute infectious disease or cold-like symptoms at the time of screening.
8.Individuals confirmed to have had blood collection or bleeding of 400 mL or more within the past 3 months, or 1200 mL or more within the past year.
9.Individuals for whom the physician has judged participation in this study to be inappropriate.

Target sample size

40

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Tatsuno

Organization

Chugai Pharmaceutical Co., Ltd.

Division name

Pharmaceutical Science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo

TEL

0120-189-706

Email

clinical-trials@chugai-pharm.co.jp

Name of contact person

1st name	Chugai Pharmaceutical Co., Ltd.
Middle name
Last name	Clinical trials information

Organization

Chugai Pharmaceutical Co., Ltd.

Division name

Clinical Strategy and Resource Management Dept.

Zip code

1038324

Address

1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo

TEL

0120-189-706

Homepage URL

Email

clinical-trials@chugai-pharm.co.jp

Institute

Chugai Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Oita University Faculty of Medicine Department of Clinical Pharmacology Therapeutics.

Name of secondary funder(s)

Organization

Oita University Faculty of Medicine Ethics Committee

Address

1-1 Idaigaoka, Hasama-cho, Yufu city, Oita

Tel

097-586-6380

Email

rinrikenkyu@oita-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

16

Day

Date of IRB

Anticipated trial start date

2026

Year

05

Month

15

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 related information

Registered date

2026

Year

05

Month

13

Day

Last modified on

2026

Year

05

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067321