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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260180

Enrollment

1000

Registered

2026-06-02

Start date

2026-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious diseases

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: When consent is withdrawn When a request to refuse secondary use is made for stored specimens originating from other research When no residual specimens remain

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public Contactaoi kimiyama

University of Tsukuba Hospital

tsukuba-idcenter@gwe.md.tsukuba.ac.jp+81-29-853-3682

Outcome results