Self-sampling for Non-attenders to Cervical Cancer Screening (KOPRETINA)

  • STATUS
    Recruiting
  • days left to enroll
    58
  • participants needed
    15000
  • sponsor
    The Institute of Molecular and Translational Medicine, Czech Republic
Updated on 22 March 2022
cancer
cancer screening
human papillomavirus
hpv vaccine
diagnostic procedures
cervical cancer screening
human papilloma virus vaccine
Accepts healthy volunteers

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.

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.

Details
Condition Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection
Treatment Self-sampling by Evalyn Brush, Self sampling by Evalyn Brush home or in GP´s clinic
Clinical Study IdentifierNCT04226313
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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 Czech Republic for at least 3 years (Arm B and C)
Women with completed informed consent
Women capable of self-sampling of cervicovaginal swab

Exclusion Criteria

Pregnant women
Women with no sexual intercourse experience
Women after hysterectomy including cervix
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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