Determining the Frequency of Anal Intraepithelial Neoplasia and the Best Screening Test in Patients With HPV-Related Gynecological Diseases

What this Trial Is About

Researchers are investigating the overall risk of anal intraepithelial neoplasia (AIN) and anal cancer in women who have survived HPV-related gynecological diseases. The study also aims to find the best screening test for detecting high-grade squamous intraepithelial lesions (HSIL) in this group. The sponsor conducting this research is PCK Marine Hospital in Gdynia. The study involves performing two types of diagnostic tests: a high-risk HPV (hrHPV) test targeting the 14 most common cancer-causing HPV types and liquid cytology samples taken from both the lower genital tract and the anal canal. Following these tests, participants undergo high-resolution anoscopy (HRA), during which suspected lesions can be biopsied or excised for detailed examination. Participants will be monitored through these diagnostic procedures before any surgical intervention. The main outcome measured is the presence of anal intraepithelial neoplasia or anal cancer just prior to surgery. The study is randomized and includes a placebo comparator group. Participation involves multiple tests and possibly biopsies, with all assessments aimed at determining the best screening approach for AIN in HPV-related gynecological disease survivors.

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.