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	jRCT1030260181

Scientific Title	Clinical Performance Testing Using the Fully Automated Genetic Testing Device GENECUBE and Respiratory Pathogen Genetic Detection Reagents in Respiratory Specimens
Public Title	Clinical Performance Testing Using the Fully Automated Genetic Testing Device GENECUBE and Respiratory Pathogen Genetic Detection Reagents in Respiratory 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	kaizu Asako
	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 respiratory infection who have new consented specimens or residual/stored specimens such as postnasal, nasopharyngeal, pharyngeal swabs, or sputum.
	Exclusion Criteria	When consent is withdrawn When a request to refuse secondary use is made for stored specimens originating from other studies When no residual specimens remain
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Infectious diseases
Health Condition(s) Keyword		Infectious diseases
Health Condition(s) Code		D003141
Primary Outcome(s)		Comparative performance evaluation of GENECUBE versus existing methods (e.g., LAMP) for M. pneumoniae detection in nasopharyngeal swabs.
Secondary Outcome(s)		Detection of M. pneumoniae variants and drug susceptibility; evaluation of B. pertussis, C. pneumoniae, C. psittaci, Legionella, Rickettsia, Coxiella; pretreatment, composition, device settings; sensitivity, reproducibility, stability; cross-reactivity; magLEAD optimization; simultaneous detection of respiratory pathogens and resistance genes.

Primary Sponsor	TOYOBO CO., LTD

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Ethics CommitteeUniversity of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Japan, 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