NCT04133610

Brief Summary

Comparison of the detection of human papillomavirus DNA in paired physician-obtained cervical swabs and self-sampled cervicovaginal swabs and evaluation of HPV prevalence in Czech women screening population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,044

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

October 16, 2019

Last Update Submit

November 25, 2019

Conditions

Cervical CancerCervical DysplasiaHuman Papillomavirus Infection

Keywords

human papillomavirusHPVself-samplingcervical swabcervicovaginal swabcervical cancer screening

Outcome Measures

Primary Outcomes (2)

  • HPV prevalence

    Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.

    18 months

  • Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs

    Paired cervical and cervicovaginal swabs will be collected in the same day and will be tested by the same method. Concordance of HPV positivity in both swabs will be evaluated.

    18 months

Secondary Outcomes (1)

  • Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.

    18 months

Study Arms (2)

Self-sampling device in media

EXPERIMENTAL

Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using self-sampling device in STM media. HPV will be detected by hybridization technique.

Diagnostic Test: Self-sampling using digene HC2 DNA Collection Device

Dry self-sampling device

EXPERIMENTAL

Women will undergo clinician-obtained cervical swab and self-sampled cervicovaginal swab using dry self-sampling device. HPV will be detected by hybridization and PCR techniques.

Diagnostic Test: Self-sampling using Evalyn Brush

Interventions

Self-sampling using digene HC2 DNA Collection DeviceDIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Self-sampling device in media
Self-sampling using Evalyn BrushDIAGNOSTIC_TEST

All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Dry self-sampling device

Eligibility Criteria

Age30 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with age 30-64 years.
  • Women attending cervical cancer screening program in Czech Republic.
  • Women with completed informed consent.

You may not qualify if:

  • Pregnant women.
  • Women with no sexual intercourse experience.
  • Women after cervical conization or hysterectomy.
  • Women with CIN or cervical carcinoma in anamnesis.
  • Women at risk of increased bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GYN-PREN, Ltd.

Frýdek-Místek, Czechia

Location

GYNPRENATAL, Ltd.

Havířov, Czechia

Location

MEDIOL, Ltd.

Olomouc, Czechia

Location

Related Publications (1)

  • Jaworek H, Bouska O, Kourilova P, Hajduch M, Koudelakova V. High-risk HPV prevalence in the Czech cervical cancer screening population: a comparison of clinician-collected and self-collected sampling. Eur J Public Health. 2025 Aug 1;35(4):760-765. doi: 10.1093/eurpub/ckaf045.

    PMID: 40194781DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical DysplasiaPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous ConditionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marian Hajduch, MD, PhD.

    Palacky University in Olomouc, Faculty of Medicine and Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

September 1, 2018

Primary Completion

October 30, 2019

Study Completion

November 25, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(3)