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

Cervical Cancer Clinical Trial

— HPVPro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133610
• Other study ID #: 343
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: November 2019
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: November 25, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Human Papillomavirus Infection
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• Self-sampling using digene HC2 DNA Collection Device
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
• Self-sampling using Evalyn Brush
All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.

Locations

Country	Name	City	State
Czechia	GYN-PREN, Ltd.	Frýdek-Místek
Czechia	GYNPRENATAL, Ltd.	Havírov
Czechia	MEDIOL, Ltd.	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	Cancer Research Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV prevalence	Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women.	18 months
Primary	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	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.	18 months