HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
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.
The samples are collected from patients referred to colposcopy because of prior cervical
 abnormalities on Pap test such as ASCUS and LSIL. The patient takes at home urine samples on
 the morning of visit to the colposcopy center. At the colposcopy center, self-collected
 vaginal samples are taken by the patient herself with a plastic brush (Flocked Swab,
 manufactured by Noble Bioscience, Inc.). Finally, the gynecologist takes a cervical sample
 with a plastic brush (Cervical Brush, manufactured by Noble Bioscience, Inc.).

 Physician collected cervical samples, self-collected vaginal samples and urine samples are
 used to perform HPV testing with Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit
 and Realtime HPV HR-S Detection kit.

 The Anyplex™ II HPV HR detection kit (manufactured by Seegene. Inc, Korea) is a new,
 multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk. (HR)
 human papillomavirus (HPV) types in a single tube.

 The Roche Cobas® 4800 HPV test (manufactured by Cobas) is a novel molecular method based on
 real-time PCR (RT-PCR), with a fully automated system allowing quick and efficient sample
 processing. Cobas can detect the human papillomavirus type 16(HPV16), the human
 papillomavirus type 18(HPV18), 12 other high-risk HPVs (hrHPVs) (HPV31, -33, -35, -39, -45,
 -51, -52, -56, -58, -59, -66, and -68, as a pooled result), and the β-globin control
 independently in the same PCR.

 Realtime HPV HR-S Detection kit (manufactured by Sejong Biomed Co, Korea) is a new, real-time
 polymerase chain reaction assay to detect HPV 16, HPV 18, 12 other high-risk HPVs (HPV31,
 -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68). Real-time HPV HR-S Detection Kit
 is based on accurate real-time PCR method as described, and it can detect 14 kinds of HPV
 type detection in a single test (HPV 16/18 genotype and others (UDG) -dUTP) system for the
 prevention of contamination, and a control agent (hemoglobin DNA, a human-derived DNA) as a
 whole process control was introduced into a high-risk genotype (12 genotypes other than HPV
 16/18). It has high sensitivity and specificity for detection of high risk genotypes by
 increasing the reliability of the results.

 The main goal of this study is to determine whether HPV testing using urine and
 self-collected sample is sensitive to detecting precancerous lesions such as cervical
 intraepithelial neoplasia(CIN)2/3 in patients diagnosed with ASCUS and LSIL on the Pap test.
 The colposcopy and histological findings will be used as the gold standard. In addition, the
 relative sensitivity and specificity for detecting HPV16, HPV18 and high risk HPV will be
 determined for each of the three HPV tests using urine and self-collected samples compared
 with the HPV tests using physician-collected samples.
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