臨床研究等提出・公開システム

Date of registration	June. 02, 2026
Last modified on	June. 04, 2026
Trial ID	jRCT1030260180

Scientific Title	Clinical Performance Study: Detection of Sexually Transmitted Infection related pathogens using GENECUBE and dedicated detection reagents in various clinical specimens
Public Title	Clinical Performance Study: Detection of Sexually Transmitted Infection related pathogens using GENECUBE and dedicated detection reagents in various clinical specimens

Contact for Scientific Queries	Name	Suzuki Hiromichi
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, 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 Hospital
	Address	2-1-1 Amakubo, Tsukuba, Ibaraki
	Telephone	+81-29-853-3682
	E-mail	tsukuba-idcenter@gwe.md.tsukuba.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 02, 2026
Target sample size		1000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients presenting with suspected STIs who have provided consent for new specimen collection, or who have residual/stored specimens such as urine, swabs, throat specimens, or vesicle/pustule swabs.
	Exclusion Criteria	When consent is withdrawn When a request to refuse secondary use is made for stored specimens originating from other research When no residual specimens remain
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Infectious diseases
Primary Outcome(s)		Clinical performance evaluation of GENECUBE multi-target STI detection assay (C. trachomatis, N. gonorrhoeae, M. genitalium with resistance mutations, M. hominis, Ureaplasma spp., T. vaginalis, T. pallidum, HSV-1, HSV-2) compared with existing methods.
Secondary Outcome(s)		Evaluation of specimen pretreatment methods, composition, and device conditions; sensitivity, reproducibility, and storage stability; cross-reactivity testing; compatibility with commercially available processing solutions; magLEAD optimization; simultaneous detection performance of multiple pathogens from the same specimen

Primary Sponsor	TOYOBO CO., LTD

Name of Certified Review Board	Ethics CommitteeUniversity of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3749
E-Mail	tcr.nintei@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	June. 23, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 04, 2026	(this page)	Changes
1	June. 02, 2026	Detail

List of change history