RecruitingNot ApplicableNCT06574087

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.

Sponsor

PCK Marine Hospital in Gdynia

Enrollment

248 participants

Start Date

Jan 13, 2023

Study Type

INTERVENTIONAL

Conditions

HPV-Related Carcinoma HPV Infection

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.

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study looks at how often anal precancerous changes (called anal intraepithelial neoplasia, or AIN) occur in people who already have HPV-related gynecological conditions, such as cervical, vaginal, or vulvar dysplasia. It also tests which screening method is best for detecting AIN. **You may be eligible if...** - You have been diagnosed with an HPV-related gynecological disease confirmed by tissue biopsy (histopathology) - Tissue samples can be collected from both the gynecological area and the anal canal **You may NOT be eligible if...** - You do not have an HPV-related gynecological condition confirmed by pathology - Samples cannot be safely collected from the required areas Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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