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

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

Inclusion Criteria2

  • HPV related gynecological disease confirmed in histo-pathological examination
  • the posibility to obtain material from gynecological organ and from anal canal

Interventions

DIAGNOSTIC_TESThrHPV test and cytology

Perfomance of hrHPV test and cytology


Locations(1)

PCK Marine Hospital in Gdynia

Gdynia, Pomeranian Voivodeship, Poland

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NCT06574087


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