Clinical Trial: Validation of sample processing and transport conditions for establishing standard operating procedures (SOPs) for blood component evaluation (Japan)

Tokyo, Oct. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063150) titled 'Validation of blood preservation and transport conditions for standardizing blood component evaluation' on Oct. 12.

Study Type: Observational

Primary Sponsor: Institute - Kewpie corporation

Condition: Condition - healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of sample processing and transport conditions on sample quality and analytical results in circulating microRNA analysis, and to establish practical standard operating procedures (SOPs). Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Healthy males and females aged 20 years or older and under 70 years at the time of informed consent 2.Individuals who voluntarily wish to participate in the study and are able to provide written informed consent 3.Individuals who have received a full explanation of the study, understand its content, and have provided written informed consent Key exclusion criteria - 1. Individuals with a current history of severe cardiac, hepatic, renal, or gastrointestinal disease, or who have been advised by a physician to undergo medical treatment based on health checkup results within the past year 2. Individuals with a current history or suspicion of anemia (abnormal hemoglobin levels) 3. Individuals with a history of vasovagal response (vasovagal syncope) during blood sampling 4. Male individuals who have donated 400 mL of whole blood within 3 months prior to the start of this study 5. Female individuals who have donated 400 mL of whole blood within 4 months prior to the start of this study 6. Individuals who tested positive or are suspected positive in infectious disease screening tests (HBs antigen, HCV 3rd generation antibody, syphilis TP antibody, HIV 1/2 antigen/antibody) 7. Other individuals deemed unsuitable for participation in the study by the principal investigator Target Size - 28

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 14 Day Date of IRB - 2026 Year 09 Month 30 Day Anticipated trial start date - 2026 Year 10 Month 24 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072279

Disclaimer: Curated by HT Syndication.