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Trial Title:
HPV DNA Self-sampling in a General Practitioner's Office.
NCT ID:
NCT06253169
Condition:
Cervical Cancer
HPV Infection
Precancerous Lesion
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
Prevention
Cervical cancer
HPV test
Self-sampling
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HPV DNA self-test
Description:
HPV DNA swab from the cervix performed by the patient herself.
Arm group label:
Not participating in screening
Arm group label:
Participating in the screening
Summary:
One of the limitations of organized cervical screening in the Czech Republic is the lack
of participation in preventive gynecological examinations. The aim of the project is to
evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient
clinics to improve population participation in cervical screening.
Detailed description:
Organized cervical screening in the Czech Republic has a long-term participation rate of
about 56% of the target population. Despite active invitations through health insurance
companies, a part of the population is resistant and does not participate in screening
visits to gynaecologists in the long term. A significant proportion of such women,
however, regularly visit their general practitioner due to other comorbidities. The aim
of the ASTRA project is to assess whether an effective way to increase the proportion of
women attending cervical screening is to perform self-testing for HPV DNA in the GP's
office.
Criteria for eligibility:
Study pop:
All women over 30 years of age who meet the entry criteria for inclusion in the study.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Signed informed consent for statistical data processing and consent to the
processing of personal data
- Age 30+
- HPV test never performed or performed more than 3 years ago or patient does not know
Exclusion Criteria:
- Refusal to participate
- Pregnancy and puerperium
- Menses
- History of hysterectomy
- HPV test performed <3 years ago with negative result
- Regular participation in screening and concurrent age 35, 45 or 55 years (test will
be performed in the same year of screening).
Gender:
Female
Minimum age:
30 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CGOP, s.r.o.
Address:
City:
Prague
Zip:
12000
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Lucie Panýrová, PhD
Phone:
+420 603 509 151
Email:
lucie.panyrova@next-clinics.com
Investigator:
Last name:
Jiří Sláma, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Lucie Mandelová, PhD
Email:
Sub-Investigator
Facility:
Name:
Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University
Address:
City:
Prague
Zip:
12000
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiří Sláma, MD PhD
Phone:
+420224967451
Email:
jiri.slama@vfn.cz
Investigator:
Last name:
Jiří Sláma, MD PhD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Patient Organization Veronica
Agency class:
Other
Source:
Patient Organization Veronica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06253169
