HPV DNA Self-sampling in a General Practitioner's Office.

NCT06253169 | Recruiting

• 1 other identifier: V01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Cancer; HPV Infection; Precancerous Lesion

Keywords

Prevention; Cervical cancer; HPV test; Self-sampling

Outcome Measures

Primary Outcomes (3)

• To assess response rates to being approached about the possibility of self-testing for HPV in both study cohorts and overall.

  To compare the proportion of women who self-test for HPV DNA in a GP office versus those who refuse to take the test. To assess the overall proportion of women who self-test and the proportion in each study cohort.

  Through study completion, an average of 1 year

• Evaluation of the frequency of positivity of the HPV tests taken.

  Compare the proportion of women who will self-test positive for HPV DNA, including an assessment of positivity for HPV 16/18 and other HPV genotypes. To assess the overall proportion of women testing positive and the proportion in each study cohort.

  Through study completion, an average of 1 year

• Evaluation of follow-up gynaecological care in women who tested positive.

  To assess what proportion of women who self-test positive for HPV DNA will accept a gynecologic exam and to assess the results of the gynecologic visit.

  Through study completion, an average of 1 year

Study Arms (2)

Not participating in screening

All women over 30 years of age who are not participating in screening or have not had a screening visit in less than 5 years.

Diagnostic Test: HPV DNA self-test

Participating in the screening

All women over 30 years of age who regularly participate in screening but have not had an HPV test in the last 3 years.

Diagnostic Test: HPV DNA self-test

Interventions

HPV DNA self-test DIAGNOSTIC_TEST

HPV DNA swab from the cervix performed by the patient herself.

Not participating in screening; Participating in the screening

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women over 30 years of age who meet the entry criteria for inclusion in the study.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Patient Organization Veronica: lead

Study Sites (2)

CGOP, s.r.o.

Prague, 12000, Czechia

RECRUITING

Department of Gynecology, Obstetrics and Neonatology, General University Hospital, First Faculty of Medicine, Charles University

Prague, 12000, Czechia

RECRUITING

Related Publications (3)

• Slama J, Dvorak V, Trnkova M, Skrivanek A, Hrabcova K, Ovesna P, Novackova M. Is phased implementation of HPV testing and triage with dual staining the way to transform organized cytology screening? Eur J Cancer Prev. 2024 Mar 1;33(2):168-176. doi: 10.1097/CEJ.0000000000000844. Epub 2023 Sep 21.

  PMID: 37751376 BACKGROUND

• Sehnal B, Slama J. What next in cervical cancer screening? Ceska Gynekol. 2020 Winter;85(4):236-243.

  PMID: 33562978 BACKGROUND

• Ngo O, Chloupkova R, Cibula D, Slama J, Mandelova L, Hejduk K, Hajduch M, Minka P, Koudelakova V, Jaworek H, Trnkova M, Vanek P, Dvorak V, Dusek L, Majek O. Direct mailing of HPV self-sampling kits to women aged 50-65 non-participating in cervical screening in the Czech Republic. Eur J Public Health. 2024 Apr 3;34(2):361-367. doi: 10.1093/eurpub/ckad229.

  PMID: 38224266 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

HPV DNA smears from the cervix

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronika Cibulová, MS

  Patient Organisation Veronica

  STUDY CHAIR

Central Study Contacts

Jiří Sláma, MD, PhD

CONTACT

+420224967451; jiri.slama@vfn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CZ (2)