Self-sampling for Non-attenders to Cervical Cancer Screening

Last updated: March 14, 2025
Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Uterine Disorders

Pelvic Cancer

Treatment

Self sampling by Evalyn Brush home or in GP´s clinic

Self-sampling by Evalyn Brush

Clinical Study ID

NCT04226313
5850
  • Ages 30-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different ways of offering self-sampling device will be evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women with age 30-65 years; for arm A women > 65 years are allowed

  • Women live in the Czech Republic.

  • Women who have not participate in cervical cancer screening program in the CzechRepublic for at least 3 years (Arm B and C).

  • Women with completed informed consent.

  • Women capable of self-sampling of cervicovaginal swab.

Exclusion

Exclusion Criteria:

  • Pregnant women.

  • Women with no sexual intercourse experience.

  • Women after hysterectomy including cervix.

Study Design

Total Participants: 15000
Treatment Group(s): 2
Primary Treatment: Self sampling by Evalyn Brush home or in GP´s clinic
Phase:
Study Start date:
September 23, 2019
Estimated Completion Date:
December 01, 2025

Study Description

Despite the existence of an effective cervical cancer screening in the Czech Republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. One of the major problem of the Czech cervical cancer screening is low participation. An effective strategy to increase cervical cancer screening attendance is one of the main challenges. The offering of self-sampling to the cervical cancer screening non-attenders could increase women's participation as was shown in several European countries.

The trial should determine acceptability of the self-sampling followed by HPV DNA test by Czech women and therefore usability of the self-sampling device to increase cervical cancer screening attendance among under-screened women. Three different approaches will be tested: women will receive a self-sampling device by mail (Arm A); receive a self-sampling device by gynecologist (Arm B); receive a self-sampling device by general practitioner (Arm C). Comparisons of the screening attendance among the arms will be made. To address also potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. Women from the database of commercial vendor will be included to the Arm A regardless of whether or not they participate in cervical cancer screening program. Women who do not participate in cytology-based cervical cancer screening program for at least three years will be included through their gynecologist (Arm B) or general practitioner (Arm C) database.

The second focus of the trial is the evaluation of high-risk human papillomavirus prevalence in screening population of Czech women (attenders and non-attenders of cervical cancer screening) since there are no relevant data for the Czech Republic. Study participants may volunteer for archiving of remaining biological materials for future studies.

Connect with a study center

  • University Hospital Olomouc

    Olomouc,
    Czechia

    Active - Recruiting

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