Feasibility of HPV DNA and vaginal infection detection by self test

Feasibility of HPV DNA and vaginal infectious disease detection in mail-delivered self obtained vaginal sample obtained by G+Kit

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007456

Enrollment

316

Registered

2022-06-29

Start date

2022-06-27

Completion date

Unknown

Last updated

2022-09-20

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

Conditions

None listed

Interventions

Medical Device : Among women aged 20 to 65 with sexual experience, after obtaining consent from patients with ASCUS or higher lesions or positive for HPV in a previous cervical test, the vaginal colle

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Among women between the ages of 20 and 65 who have had sexual experiences, patients with more severe lesions than ASCUS and positive for HPV in a previous cervical test

Exclusion criteria

Exclusion criteria: 1) women without sexual experience 2) women who are currently menstruating or when it is impossible to collect a sample due to another disease 3) women who are unable to read the manual and follow instructions 4) when the researcher determines that the research cannot be conducted due to other diseases

Design outcomes

Primary

Measure	Time frame
Statistical agreement on sensitivity and specificity between the results of self-collected samples and those of physician-collected samples	—

Secondary

Measure	Time frame
The values of sensitivity and specificity of both tests	—

Countries

Korea, Republic of

Contacts

Public ContactDongryung Shin

Korea Cancer Center Hospital

shindongryung@kirams.re.kr+82-2-970-1651

Outcome results