Status:
UNKNOWN
HPV Test of Urine and Self Collected Vaginal Samples for Cervical Cancer Screening Study
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Korea Health Industry Development Institute
Cheil General Hospital and Women's Healthcare Center
Conditions:
ASC-US
LSIL
Eligibility:
FEMALE
20-60 years
Brief 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 signific...
Detailed Description
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 vis...
Eligibility Criteria
Inclusion
- Women with previous abnormal Pap test results (ASCUS, LSIL)
- Women between the ages of 20 and 60
Exclusion
- 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
Key Trial Info
Start Date :
May 4 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03409471
Start Date
May 4 2018
End Date
February 28 2019
Last Update
August 24 2018
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea, 08308