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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-07-23

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

hrHPV test and cytology

Perfomance of hrHPV test and cytology

Sponsors & Collaborators

  • Medical University of Gdansk

    collaborator OTHER

  • National Science Centre, Poland

    collaborator OTHER_GOV

  • PCK Marine Hospital in Gdynia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574087 on ClinicalTrials.gov