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	jRCT1030260178

Scientific Title	Detection of Mycobacterial Pathogens in Clinical Specimens Using GENECUBE and Dedicated Detection Reagents
Public Title	Detection of Mycobacterial Pathogens in Clinical Specimens Using GENECUBE and Dedicated Detection Reagents

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		500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients aged 18 years or older presenting with suspected acid-fast bacilli infections who have residual sputum specimens obtained during routine clinical care.
	Exclusion Criteria	When the quantity of residual specimen is insufficient
	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)		Clinical performance evaluation of GENECUBE mycobacterial assays (M. tuberculosis, M. avium, M. intracellulare) and sputum pretreatment with Sputase versus existing methods.
Secondary Outcome(s)		Evaluation of basic performance and inter-strain variability including improved methods, compatibility with commercially available processing methods, comparison with conventional processing methods, and evaluation of reagents for M. abscessus, M. kansasii, resistance genes, NTM, M. tuberculosis, and BCG

Primary Sponsor	University of Tsukuba Hospital

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	Nov. 22, 2024

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