Self-sampling for Non-attenders to Cervical Cancer Screening

Cervical Cancer Clinical Trial

— KOPRETINA  

Official title:

Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226313
• Other study ID #: 5850
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: Marian Hajduch, MD, PhD.
• Phone: +420 585 632 083
• Email: marian.hajduch[@]upol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Human Papillomavirus Infection
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	Cancer Research Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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