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.

Last updated: August 23, 2024
Sponsor: PCK Marine Hospital in Gdynia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

hrHPV test and cytology

Clinical Study ID

NCT06574087
PCK01
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HPV related gynecological disease confirmed in histo-pathological examination

  • the posibility to obtain material from gynecological organ and from anal canal

Study Design

Total Participants: 248
Treatment Group(s): 1
Primary Treatment: hrHPV test and cytology
Phase:
Study Start date:
January 13, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • PCK Marine Hospital in Gdynia

    Gdynia, Pomorskie 81-519
    Poland

    Active - Recruiting

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