Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
- Conditions
- HPV-Related CarcinomaHPV Infection
- Registration Number
- NCT06574087
- Lead Sponsor
- PCK Marine Hospital in Gdynia
- Brief Summary
The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and histopathological examination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 248
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anal intraepithelial neoplasm/ anal cancer Just before surgery Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PCK Marine Hospital in Gdynia
🇵🇱Gdynia, Pomorskie, Poland
PCK Marine Hospital in Gdynia🇵🇱Gdynia, Pomorskie, PolandMichał BrzezińskiPrincipal InvestigatorMaciej StukanSub Investigator