NCT03409471

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 4, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

January 18, 2018

Last Update Submit

August 22, 2018

Conditions

ASC-USLSIL

Keywords

UrineCervical Intraepithelial NeoplasiaSelf-SamplingHPV TestingCervical Cancer ScreeningASCUSLSIL

Outcome Measures

Primary Outcomes (1)

  • Clinical accuracy

    Absolute sensitivity and specificity for finding underlying cervical intraepithelial neoplasia(CIN)2+ of HPV testing(Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit) on urine, self- and clinician-collected samples.

    Within 6 months after study completion

Secondary Outcomes (2)

  • Clinical accuracy

    Within 6 months after study completion

  • Analytical performance

    Within 6 months after study completion

Interventions

Flocked SwabDEVICE

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

Cervical BrushDEVICE

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

HPV assayDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

300 women visited to a participating colposcopy centers (Korea University Guro Hospital, Korea University Ansan Hospital, Seoul Samsung Medical Center and Cheil General Hospital and Women's Healthcare Center), because of a previous abnormal Pap test result (ASCUS, LSIL), will be enrolled after obtaining informed consent.

You may qualify if:

  • Women with previous abnormal Pap test results (ASCUS, LSIL)
  • Women between the ages of 20 and 60

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Related Publications (7)

  • Jung S, Lee B, Lee KN, Kim Y, Oh EJ. Clinical Validation of Anyplex II HPV HR Detection Test for Cervical Cancer Screening in Korea. Arch Pathol Lab Med. 2016 Mar;140(3):276-80. doi: 10.5858/arpa.2015-0117-OA.

    PMID: 26927723BACKGROUND

  • Cui M, Chan N, Liu M, Thai K, Malaczynska J, Singh I, Zhang D, Ye F. Clinical performance of Roche Cobas 4800 HPV Test. J Clin Microbiol. 2014 Jun;52(6):2210-1. doi: 10.1128/JCM.00883-14. Epub 2014 Apr 9.

    PMID: 24719443BACKGROUND

  • Stanczuk GA, Currie H, Baxter G, Foster A, Gibson L, Graham C, Cuschieri K. Cobas 4800 HPV detection in the cervical, vaginal and urine samples of women with high-grade CIN before and after treatment. J Clin Pathol. 2015 Jul;68(7):567-70. doi: 10.1136/jclinpath-2014-202851. Epub 2015 Apr 15.

    PMID: 25878328BACKGROUND

  • Connor RJ. Sample size for testing differences in proportions for the paired-sample design. Biometrics. 1987 Mar;43(1):207-11.

    PMID: 3567305BACKGROUND

  • Stanczuk G, Baxter G, Currie H, Lawrence J, Cuschieri K, Wilson A, Arbyn M. Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway-PaVDaG study). BMJ Open. 2016 Apr 25;6(4):e010660. doi: 10.1136/bmjopen-2015-010660.

    PMID: 27113237BACKGROUND

  • Guan P, Howell-Jones R, Li N, Bruni L, de Sanjose S, Franceschi S, Clifford GM. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Int J Cancer. 2012 Nov 15;131(10):2349-59. doi: 10.1002/ijc.27485. Epub 2012 Mar 20.

    PMID: 22323075BACKGROUND

  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

    PMID: 843571BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample, vaginal self-sample and cervical cell sample collected by a gynecologist. No human DNA is extracted from the samples but the samples can contain HPV DNA.

MeSH Terms

Conditions

Atypical Squamous Cells of the CervixUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Study Officials

  • Jae Kwan Lee, MD, Ph.D.

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Kwan Lee, MD, Ph.D.

CONTACT

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

Hyun Woong Cho, MD

CONTACT

82-2-2626-3147limpcho82@korea.ac.kr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

May 4, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)