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

The Institute of Molecular and Translational Medicine, Czech Republic

Status: Enrolling

Conditions: Human Papillomavirus Infection; Cervical Dysplasia; Cervical Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04226313

5850

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15,000 participants in 3 patient groups

Self-sampling device sent at home

Active Comparator group

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.

Treatment:

Diagnostic Test: Self-sampling by Evalyn Brush

Self-sampling device sent by gynecologist(s)

Experimental group

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.

Treatment:

Diagnostic Test: Self-sampling by Evalyn Brush

Self-sampling device obtained from general practitioner(s)

Experimental group

Description:

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.

Treatment:

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