Self-sampling for Non-attenders to Cervical Cancer Screening
NCT ID: NCT04226313
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
15000 participants
INTERVENTIONAL
2019-09-23
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs
NCT04133610
The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples
NCT04423679
Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
NCT00977392
Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening
NCT03873376
Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
NCT02651883
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-sampling device sent at home
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.
Self-sampling by Evalyn Brush
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
Self-sampling device sent by gynecologist(s)
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.
Self-sampling by Evalyn Brush
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
Self-sampling device obtained from general practitioner(s)
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.
Self sampling by Evalyn Brush home or in GP´s clinic
Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Self-sampling by Evalyn Brush
Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
Self sampling by Evalyn Brush home or in GP´s clinic
Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Women with no sexual intercourse experience.
* Women after hysterectomy including cervix.
30 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Cancer Research, Czech Republic
OTHER
The Institute of Molecular and Translational Medicine, Czech Republic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marian Hajduch, MD, PhD.
Role: STUDY_DIRECTOR
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Olomouc
Olomouc, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5850
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.