臨床研究等提出・公開システム

Date of registration	Jan. 26, 2024
Last modified on	May. 27, 2026
Trial ID	jRCT1032230598

Scientific Title	Clinical performance test: Acute exanthematous disease pathogen detection using GENECUBE and dedicated detection reagents in various clinical samples.
Public Title	Clinical performance test: Acute exanthematous disease pathogen detection using GENECUBE and dedicated detection reagents in various clinical samples.

Contact for Scientific Queries	Name	Suzuki Hiromichi
	Affiliation	University of Tsukuba Hospital
	Address	1-1-1 Tennodai, Tsukuba, Ibaraki
	Telephone	+81-29-853-3682
	E-mail	hsuzuki@md.tsukuba.ac.jp
Contact for Public Queries	Name	Kimiyama Aoi
	Affiliation	University of Tsukuba
	Address	1-1-1 Tennodai, Tsukuba, Ibaraki
	Telephone	+81-298533682
	E-mail	tsukuba-idcenter@md.tsukuba.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		April. 21, 2023
Actual date of first enrollment		May. 12, 2023
Target sample size		1000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Male and female patients over the age of 18 years were suspected of suffering from acute exanthematous diseases who had visited associated facilities and gave their consent in writing to participate through co-investigators.
	Exclusion Criteria	When a request is made to withdraw consent
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Infectious diseases
Health Condition(s) Keyword		Infectious diseases
Primary Outcome(s)		Minimum detection sensitivity, reproducibility, and storage stability of selective multiple simultaneous pathogen detection reagents.
Secondary Outcome(s)		None

Primary Sponsor	University of Tsukuba Hospital

Source of Monetary Support	TOYOBO CO., LTD.
Secondary Sponsor

Name of Certified Review Board	Ethics CommitteeUniversity of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Japan, Ibaraki
Telephone	+81-29-853-5669
E-Mail	t-credo.adm@un-tsukuba.ac.jp
Approval Status	Approval
Date of approval	April. 15, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 27, 2026	(this page)	Changes
1	Jan. 26, 2024	Detail

List of change history