Actively Recruiting

Phase Not Applicable
FEMALE
Healthy Volunteers
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.

Led by PCK Marine Hospital in Gdynia · Updated on 2025-07-23

248

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

P

PCK Marine Hospital in Gdynia

Lead Sponsor

M

Medical University of Gdansk

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • HPV related gynecological disease confirmed in histo-pathological examination
  • The possibility to obtain material from gynecological organ and from anal canal
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

PCK Marine Hospital in Gdynia

Gdynia, Pomeranian Voivodeship, Poland, 81-519

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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