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.
Not Applicable
Recruiting
- Conditions
- HPV-Related CarcinomaHPV Infection
- Interventions
- Diagnostic Test: hrHPV test and cytology
- 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
Inclusion Criteria
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HPV- related gynecological disease arm hrHPV test and cytology - Placebo arm hrHPV test and cytology -
- Primary Outcome Measures
Name Time Method HPV in the anal cancer Just before surgery The presence of HPV in the anal cancer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PCK Marine Hospital in Gdynia
🇵🇱Gdynia, Pomorskie, Poland