Clinical trial · Interventional
Self-sampling for Non-attenders to Cervical Cancer Screening
Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
NCT04226313CI-TRIAL-00106241KOPRETINArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-sampling by Evalyn Brush | Diagnostic Test | — | UNRESOLVED |
| Self sampling by Evalyn Brush home or in GP´s clinic | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Self-sampling device sent at home
- description
- 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.
- interventionNames
- Diagnostic Test: Self-sampling by Evalyn Brush
- type
- EXPERIMENTAL
- label
- Self-sampling device sent by gynecologist(s)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.