Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
FEMALE
Healthy Volunteers
ID04226313

Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection

Led by The Institute of Molecular and Translational Medicine, Czech Republic · Updated on 2026-03-23

15000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

The Institute of Molecular and Translational Medicine, Czech Republic

Lead Sponsor

N

National Institute for Cancer Research, Czech Republic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether self-sampling combined with human papillomavirus (HPV) testing can increase cervical cancer screening among women in the Czech Republic who have not been regularly screened. Cervical cancer remains a significant health issue there, causing around 800 new cases and 400 deaths yearly, largely due to low screening participation. This trial aims to find effective methods to encourage more women to participate in screening and to assess the prevalence of high-risk HPV in the population. The trial compares three ways of offering a self-sampling device called the Evalyn Brush: sending it by mail to women randomly selected from a commercial database, mailing it via gynecologists to women who have not participated in screening for at least three years, and providing it through general practitioners to similar non-attending women. Participants perform cervicovaginal self-sampling at home or at their general practitioner's clinic, and the collected samples are tested with an approved HPV DNA diagnostic test. The study includes about 5,000 women in each group. Participants will be women aged 30 to 65 years (with some allowance above 65 in one group) living in the Czech Republic who are capable of self-sampling. The research team will collect and analyze participation rates in screening over 12 months, HPV prevalence, and sociodemographic data. Women may also volunteer to have leftover biological samples stored for future research. The study monitors outcomes related to screening attendance and HPV presence to better understand how to improve cervical cancer prevention efforts.

CONDITIONS

Brief Title

Self-sampling for Non-attenders to Cervical Cancer Screening

Who Can Participate

Age: 30Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 30 to 65 years; women over 65 allowed in Arm A
  • Women living in the Czech Republic
  • Women who have not participated in cervical cancer screening for at least 3 years (Arm B and C)
  • Women who have provided informed consent
  • Women capable of performing cervicovaginal self-sampling
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Women who have never had sexual intercourse
  • Women who have had a hysterectomy including removal of the cervix

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote as applicable)

Surveillance

Duration - 12 months

Participants perform cervicovaginal self-sampling at home or at their general practitioner's or gynecologist's clinic using a provided self-sampling device to detect high-risk HPV.

1 self-sampling at home or clinic

Trial Site Locations

Total: 1 location

1

University Hospital Olomouc

Olomouc, Czechia

Actively Recruiting

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Research Team

M

Marian Hajduch, MD, PhD.

V

Vladimira Koudelakova, MSc, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

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