Brief Title
Self-sampling for Non-attenders to Cervical Cancer Screening
Official Title
Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection
Brief 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.
Detailed 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.
Study Type
Interventional
Primary Outcome
Screening participation
Secondary Outcome
Sociodemographic characteristics
Condition
Cervical Cancer
Intervention
Self-sampling by Evalyn Brush
Study Arms / Comparison Groups
Self-sampling device sent at home
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
15000
Start Date
September 23, 2019
Completion Date
December 1, 2023
Primary Completion Date
December 1, 2023
Eligibility Criteria
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.
Gender
Female
Ages
30 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Marian Hajduch, MD, PhD., +420 585 632 083, [email protected]
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT04226313
Organization ID
5850
Responsible Party
Sponsor
Study Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators
Cancer Research Czech Republic
Study Sponsor
Marian Hajduch, MD, PhD., Study Director, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Verification Date
March 2023