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.
NCT06574087 · NA · Gdynia, Pomeranian Voivodeship, Poland
- Condition
- Colorectal Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- DIAGNOSTIC_TEST
- Intervention
- hrHPV test and cytology
- Age
- 18 Years and older
- Gender
- Female
- Sponsor
- PCK Marine Hospital in Gdynia
- Research institution
- PCK Marine Hospital in Gdynia
- Facility
- PCK Marine Hospital in Gdynia
- Research center
- PCK Marine Hospital in Gdynia
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.
Inclusion criteria
Inclusion Criteria: * HPV related gynecological disease confirmed in histo-pathological examination * the posibility to obtain material from gynecological organ and from anal canal
Primary outcomes
Anal intraepithelial neoplasm/ anal cancer