Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
Who is this study for? Older adult female patients in Czech
What treatments are being studied? Evalyn Brush
Status: Recruiting
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:
• 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.
Contact Information
Primary
Marian Hajduch, MD, PhD.
marian.hajduch@upol.cz
+420 585 632 083
Backup
Vladimira Koudelakova, MSc, Ph.D.
vladimira.koudelakova@upol.cz
+420 585 632 089
Time Frame
Start Date: 2019-09-23
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 15000
Treatments
Active_comparator: Self-sampling device sent at home
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.
Experimental: Self-sampling device sent by gynecologist(s)
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.
Experimental: Self-sampling device obtained from general practitioner(s)
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.
Related Therapeutic Areas
Sponsors
Leads: The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators: National Institute for Cancer Research, Czech Republic