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HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs (HPVPro)

Primary Purpose

Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Self-sampling using digene HC2 DNA Collection Device
Self-sampling using Evalyn Brush
Sponsored by
The Institute of Molecular and Translational Medicine, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening

Eligibility Criteria

30 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • GYN-PREN, Ltd.
  • GYNPRENATAL, Ltd.
  • MEDIOL, Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Self-sampling device in media

Dry self-sampling device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.
Hybridization and PCR-based HPV detection methods will be tested in both cervical and cervicovaginal swabs and results of these two methods will be compared.

Full Information

First Posted
October 16, 2019
Last Updated
November 25, 2019
Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators
Cancer Research Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04133610
Brief Title
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
Acronym
HPVPro
Official Title
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators
Cancer Research Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The cervical screening program in the Czech Republic is based on cytology with HPV triage. Nevertheless, cytology-based cervical screening may switch to HPV-based cervical screening in future. The implementation of primary HPV screening and insuficiency cervical screening attendance are a major challenge. The offering of self-sampling to the cervical screening non-attenders could increase women's participation as was shown in several European countries. The objective of the HPVPro study was to find out the HPV prevalence in the screening population of Czech women since there are no data for the Czech Republic. The second objective was to compare HPV DNA detection rate in paired self-sampled cervicovaginal swabs and physician-obtained cervical swabs and to determine acceptability of self-sampling HPV DNA test by Czech women. This information is important for optimisation of cervical cancer screening program in the Czech Republic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection
Keywords
human papillomavirus, HPV, self-sampling, cervical swab, cervicovaginal swab, cervical cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1044 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-sampling device in media
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry self-sampling device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-sampling using digene HC2 DNA Collection Device
Intervention Description
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-sampling using Evalyn Brush
Intervention Description
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
Primary Outcome Measure Information:
Title
HPV prevalence
Description
Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.
Time Frame
18 months
Title
Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.
Description
Hybridization and PCR-based HPV detection methods will be tested in both cervical and cervicovaginal swabs and results of these two methods will be compared.
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with age 30-64 years. Women attending cervical cancer screening program in Czech Republic. Women with completed informed consent. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Hajduch, MD, PhD.
Organizational Affiliation
Palacky University in Olomouc, Faculty of Medicine and Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
GYN-PREN, Ltd.
City
Frýdek-Místek
Country
Czechia
Facility Name
GYNPRENATAL, Ltd.
City
Havířov
Country
Czechia
Facility Name
MEDIOL, Ltd.
City
Olomouc
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs

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