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

NCT04133610CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Enrollment

1044

Start Date

2018-09-01

Completion Date

2019-10-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Self-sampling using digene HC2 DNA Collection DeviceSelf-sampling using Evalyn Brush

Conditions

Cervical CancerCervical DysplasiaHuman Papillomavirus Infection

Eligibility

Age Range

30 Years – 64 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

HPV prevalence

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

Time frame: 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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 18 months

Locations

GYN-PREN, Ltd., Frýdek-Místek, Czechia

GYNPRENATAL, Ltd., Havířov, Czechia

MEDIOL, Ltd., Olomouc, Czechia

Linked Papers

High-risk HPV prevalence in the Czech cervical cancer screening population: a comparison of clinician-collected and self-collected sampling

Abstract The prevalence of high-risk human papillomavirus (hrHPV) types varies across countries, making it essential to estimate prevalence using nationwide samples. Data on hrHPV prevalence in the Czech Republic are very limited. This study aimed to determine the prevalence of various hrHPV types in an unselected screening population of Czech women aged 30–65 years, using paired clinician-obtained cervical swab (CS) and self-collected cervicovaginal swabs (CVS). A total of 1026 eligible women were recruited into two study arms. In arm A, the digene® HC2 DNA Collection Device was used for both CS and CVS. In arm B, the Evalyn Brush was used for CVS, while the Cervex Brush was used for CS. All samples were tested for hrHPV using the digene® HC2 High-Risk HPV DNA Test and genotyped with the PapilloCheck® HPV-Screening assay. The overall hrHPV prevalence was 14.8%, based on positive results from either CVS or CS samples. hrHPV positivity was detected in 10.8% of clinician-obtained CSs and 11.8% of self-collected CVSs. A combined analysis of CS and CVS samples identified the five most prevalent hrHPV genotypes: HPV16, HPV31, HPV39, HPV56, and HPV68. The comparison of hrHPV detection in paired CS and CVS samples showed an overall concordance of 93%. These findings highlight the importance of detecting hrHPV genotypes alongside conventional Pap testing in national cervical screening programs. Furthermore, the results confirm that self-sampling kits represent a suitable alternative to clinician-collected samples. Clinical trials registration ClinicalTrials.gov Identifier (NCT04133610)

Linked Investigators

Vladimira Koudelakova