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| Name | Class |
|---|---|
| National Institute for Cancer Research, Czech Republic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-sampling by Evalyn Brush | Diagnostic Test | Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic characteristics | Comparison the distribution of sociodemographic characteristics (education, age, place of residence) and reasons for previous non-attendance for screening by intervention and attendance status in women who return a questionnaire. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Marian Hajduch, MD, PhD. | IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Olomouc | Recruiting | Olomouc | Czechia |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |