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 range20 Years – 60 Years

SexFEMALE

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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

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