臨床研究等提出・公開システム

Scientific Title	Skin testing and in vitro allergy tests in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis and improve the accuracy of in vitro allergy tests: A preliminary study
Public Title	Laboratory tests to support the clinical diagnosis of anaphylaxis in healthy volunteers

Contact for Scientific Queries	Name	Takazawa Tomonori
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan
	Telephone	+81-27-220-8698
	E-mail	takazawt@gunma-u.ac.jp
Contact for Public Queries	Name	Takazawa Tomonori
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan
	Telephone	+81-27-220-8698
	E-mail	takazawt@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 21, 2022
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) A volunteer who is 20 years or older 2) A volunteer whose written consent has been obtained regarding participation in this study
	Exclusion Criteria	1)A pregnant woman /A patient who has a possibility of pregnancy 2)A volunteer taking beta-blocker 3)A volunteer taking steroid 4)A volunteer with a history of perioperative anaphylaxis 5)A volunteer who cannot stop taking antihistamines
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		anaphylaxis
Intervention(s)		Perform a prick test and an intradermal test to confirm the negative for the drug. Blood is collected and the control value in the in-vitro test is measured.
Health Condition(s) Keyword		anaphylaxis
Intervention(s) Keyword		skin testing
Health Condition(s) Code		D000707
Intervention(s) Code		D012882
Primary Outcome(s)		Seeking the optimum concentrations of drugs for in vitro tests.
Secondary Outcome(s)		Exploring the methods which improve the accuracies of in vitro tests.

Primary Sponsor	Gunma University Hospital

Secondary Sponsor

Source of Monetary Support	KAKENHI, Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa-machi, Maebashi, Gunma, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 24, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none