Clinical trial Recruiting at 1 site Interventional Women only

Assessing screening methods for anal intraepithelial neoplasia in HPV patients

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.

Run by PCK Marine Hospital in Gdynia · NCT06574087 · Data updated 2026-11-12

This study is testing different screening methods to see which one best finds anal cell changes in people who have survived HPV-related cancers.

Quick facts

Study typeInterventional
SexWomen only
Enrollment248 (estimated)
SponsorPCK Marine Hospital in Gdynia
Academic / other
Locations1 site (Gdynia, Pomeranian Voivodeship)
StatusRecruiting
StartedJanuary 13, 2023
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedJuly 23, 2025
Trial IDNCT06574087 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals with confirmed HPV-related gynecological diseases who can provide samples from both the gynecological organ and anal canal.

Probably not a fit

Patients without a confirmed HPV-related gynecological disease or those unable to provide the necessary samples may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the frequency of anal intraepithelial neoplasia (AIN) in patients who have survived HPV-related gynecological diseases. It will identify the risk of AIN associated with various HPV-related precancers and cancers. The study will utilize high-risk HPV testing and liquid cytology from both the lower genital tract and anal canal, followed by high-resolution anoscopy for potential biopsy and histopathological examination. The goal is to determine the most effective screening test for detecting AIN in this patient population.

Why it matters

Potential benefit: If successful, this study could lead to improved screening methods for early detection of anal cancer in HPV patients, potentially reducing morbidity and mortality.

How similar studies have gone: While there have been studies on HPV and anal cancer, this specific approach to screening AIN in HPV patients is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Where it's running

  • PCK Marine Hospital in Gdynia
    Gdynia, Pomeranian Voivodeship, Poland
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.