NCT06574087

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: PCK Marine Hospital in Gdynia · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• HPV-Related Carcinoma
• HPV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	hrHPV test and cytology	Perfomance of hrHPV test and cytology

Timeline

• Start date: 2023-01-13
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-08-27
• Last updated: 2025-07-23

Locations

1 site across 1 country: Poland