MedTrace Logo

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

NCT03409471 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-08-24

No results posted yet for this study

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.

Conditions

  • ASC-US
  • LSIL

Interventions

DEVICE

Flocked Swab

At the colposcopy clinic, vaginal self-sample will be collected with the Flocked Swab (Noble Bioscience, Inc., Korea).

DEVICE

Cervical Brush

Physician collected cervical sample will be collected also at the colposcopy center with the Cervical Brush (Noble Bioscience, Inc., Korea).

DIAGNOSTIC_TEST

HPV assay

The hrHPV assay used, will be the Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Cheil General Hospital and Women's Healthcare Center

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Korea University

    collaborator OTHER

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Jae Kwan Lee, MD, Ph.D. · Professor

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2019-02-28
Completion
2019-02-28
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409471 on ClinicalTrials.gov