UnknownNot Applicable

HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study

South Korea300 participantsStarted 2018-05-04

Plain-language summary

This study is a prospective observational study of human papillomavirus (HPV) testing using urine and self-collected vaginal samples for women who have atypical squamous cells of undetermined significance(ASCUS) or low grade squamous intraepithelial lesion(LSIL) on Pap test. Among women who are diagnosed with ASCUS and LSIL, HPV test is performed by collecting urine and self-collected vaginal sample in standardized condition before colposcopy, and evaluation will be performed as a primary screening test with cytology triage.

Who can participate

Age range

20 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with previous abnormal Pap test results (ASCUS, LSIL) * Women between the ages of 20 and 60 Exclusion Criteria: * Hysterectomised women * Women with known pregnancy * Non-consenting women * Women that are not able to understand and to sign the informed consent * Women who diagnosed and treated for cervical cancer or other malignancies * Concurrent diseases that are immunosuppressed or require the use of immune-suppressants

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical accuracy

Timeframe: Within 6 months after study completion

Trial details

NCT IDNCT03409471

SponsorKorea University Guro Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-28

Contact for this trial

Jae Kwan Lee, MD, Ph.D.

82-2-2626-3142 jklee38@korea.ac.kr

View on ClinicalTrials.gov More ASC-US trials