Clinical trial NCT04133610: HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
Official title: HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Cervical Dysplasia
Human Papillomavirus Infection
Keywords: human papillomavirus
HPV
self-sampling
cervical swab
cervicovaginal swab
cervical cancer screening
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: Cancer Research Czech Republic
First posted: 2019-10-21
Enrollment: 1044
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: HPV prevalence
timeFrame: 18 months
measure: Concordance of HPV positivity in self-collected cervicovaginal swabs and clinician-collected cervical swabs
timeFrame: 18 months
Secondary outcomes:
measure: Comparison of different human papillomavirus DNA detection methods in cervical and cervicovaginal swabs.
timeFrame: 18 months
Other outcomes:
Locations:
city: Frýdek-Místek
country: Czechia
facility: GYN-PREN, Ltd.
city: Havířov
country: Czechia
facility: GYNPRENATAL, Ltd.
city: Olomouc
country: Czechia
facility: MEDIOL, Ltd.
Study officials:
affiliation: Palacky University in Olomouc, Faculty of Medicine and Dentistry
name: Marian Hajduch, MD, PhD.
role: STUDY_DIRECTOR
References: