Clinical Trial: 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 (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061554) titled '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' on May 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Chugai Pharmaceutical Co., Ltd.

Condition: Condition - Diseases requiring blood collection for clinical laboratory tests. Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Blood samples are collected using Tasso Mini.

Eligibility: 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 Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 16 Day Anticipated trial start date - 2026 Year 05 Month 15 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067321

Disclaimer: Curated by HT Syndication.