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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04133610
Other study ID # 343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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