Self-sampling for Non-attenders to Cervical Cancer Screening

NCT04226313 | Recruiting

• 1 other identifier: 5850
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; Cervical Dysplasia; Human Papillomavirus Infection

Keywords

human papillomavirus; HPV; self-sampling; cervicovaginal swab; cervical cancer screening; non-attendance

Outcome Measures

Primary Outcomes (2)

• Screening participation

  Comparison of the percentages of women who return a cervicovaginal swab sampled by self-sampling device in different arms of the study. Identification of the best approach to address women who do not participate in standard cervical cancer screening program

  12 months

• Prevalence of high-risk HPV

  Evaluation of the prevalence of high-risk human papillomavirus infection in screening population of Czech women within different arms of the study (attenders/non-attenders).

  12 months

Secondary Outcomes (1)

• Sociodemographic characteristics

  12 months

Study Arms (3)

Self-sampling device sent at home

ACTIVE COMPARATOR

Women randomly selected from a commercial vendor database (both attenders and non-attenders) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked (Conformité Européenne, In Vitro Diagnostics) HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants.

Diagnostic Test: Self-sampling by Evalyn Brush

Self-sampling device sent by gynecologist(s)

EXPERIMENTAL

Women selected from databases of cooperating gynecologists (non-attenders for at least 3 years) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device provided). Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants.

Diagnostic Test: Self-sampling by Evalyn Brush

Self-sampling device obtained from general practitioner(s)

EXPERIMENTAL

Women selected from databases of cooperating general practitioners (non-attenders for at least 3 years) receive a self-sampling device. Returned self-sampled swabs will be tested by CE-IVD-marked HPV diagnostic test validated for use in primary cervical cancer screening. The arm will include approx. 5000 participants.

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

Interventions

Self-sampling by Evalyn Brush DIAGNOSTIC_TEST

Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.

Self-sampling device sent at home; Self-sampling device sent by gynecologist(s)

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

Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush

Self-sampling device obtained from general practitioner(s)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women.
• Women with no sexual intercourse experience.
• Women after hysterectomy including cervix.

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead
• National Institute for Cancer Research, Czech Republic: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marian Hajduch, MD, PhD.

  IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

  STUDY DIRECTOR

Central Study Contacts

Marian Hajduch, MD, PhD.

CONTACT

+420 585 632 083; marian.hajduch@upol.cz

Vladimira Koudelakova, MSc, Ph.D.

CONTACT

+420 585 632 089; vladimira.koudelakova@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: September 23, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)