Acceptability of urine and self collected sample for Human papillomavirus test

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002420

Enrollment

Registered

2017-08-25

Start date

2017-05-28

Completion date

Unknown

Last updated

2019-03-11

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 : We analyzed the accuracy and agreement of HPV test using urine and self collected samples compared to conventional sample for women who had HPV infection and were diagnosed with CIN2

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Women diagnosed with CIN2 + or more (2) Women undergoing cone resection for CIN2 + (3) Women undergoing laparoscopic surgery for uterine or ovarian disease without cervical disease

Exclusion criteria

Exclusion criteria: (1) Those who have immunosuppressive disease or are taking immunosuppressive drugs (2) Those who are receiving chemotherapy with other malignant tumors (3) Participants in other clinical trials (4) Those who do not agree with the consent to participate in clinical trials

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of HPV 16, HPV 18, and HPV Other HR 12 in urine and self collected samples are assessed using Realtime HPV HR-S Detection.	—

Secondary

Measure	Time frame
Evaluating match / concordance rates - Assessment of agreement / concordance for HPV 16, 18, and Other HR 12 in urine and self collected samples are assessed using Realtime HPV HR-S Detection.	—

Countries

Korea, Republic of

Contacts

Public ContactHyun-Woong Cho

Koera University Guro Hospital

limpcho82@daum.net+82-2-2626-3147

Outcome results