About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
HPV related gynecological disease confirmed in histo-pathological examination
the posibility to obtain material from gynecological organ and from anal canal
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
hrHPV test and cytology
Diagnostic testPerfomance of hrHPV test and cytology
Treatment groups
Trial outcomes
Primary outcomes
Anal intraepithelial neoplasm/ anal cancer
Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
PCK Marine Hospital in Gdynia
Lead sponsor
Medical University of Gdansk
Collaborator
National Science Centre, Poland
Collaborator