Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057649) titled 'A study on the evaluation methodology of cell function characteristics using a newly developed flow cytometric technology' on April 18.
Study Type:
Observational
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Healthy male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the methodology for assessing cell morphology, function, classification, and other cellular characteristics using a newly developed flow cytometric technology capable of acquiring cell morphological information.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy male/female Individuals ranging in age from 20 to 59, at informed consent.
(2) Individuals 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) Individuals being under some kind of continuous medical treatment, except applying a nasal spray and eye drops.
(2) Individuals who took a steroid within the last three months from the time point of clinic visiting.
(3) Individuals who apply a steroid all the year around, except a seasonal use and deteriorating conditions.
(4) Individuals who were vaccinated within the past two weeks to the clinic visiting.
(5) Individuals touching excessive alcohol.
(6) Individuals with serious drug and/or food allergy.
(7) Individuals who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after this research.
(8) Individuals with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(9) Females who are pregnant or lactating.
(10) Individuals who donated 200 mL of their blood or blood components within the last month.
(11) Individuals who donated 400 mL of his blood within the last 3 months.
(12) Individuals who donated 400 mL of her blood within the last 4 months.
(13) Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
(14) Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
(15) Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 03 Month 24 Day
Date of IRB - 2025 Year 03 Month 21 Day
Anticipated trial start date - 2025 Year 04 Month 21 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=R000065583
Disclaimer: Curated by HT Syndication.
