Self-sampling for Non-attenders to Cervical Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Pregnant women.
Women with no sexual intercourse experience.
Women after hysterectomy including cervix.
Trial design
Design model
Parallel
Treatments tested in this trial
Self-sampling by Evalyn Brush
Diagnostic testWomen will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
Self sampling by Evalyn Brush home or in GP´s clinic
Diagnostic testWomen will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
Treatment groups
15,000 Participants
are divided into 3 treatment groupsGroup A: Self-sampling device sent at homeActive comparator 1 intervention
Group B: Self-sampling device sent by gynecologist(s)Experimental treatment 1 intervention
Group C: Self-sampling device obtained from general practitioner(s)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months2
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).
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Institute of Molecular and Translational Medicine, Czech Republic
Lead sponsor
National Institute for Cancer Research, Czech Republic
Collaborator
Source ClinicalTrials.gov