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.

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.

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Key information

Conditions

HPV-Related Carcinoma Anus Diseases Anus Neoplasms Colorectal Neoplasms Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases HPV Infection Infections Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

PCK Marine Hospital in Gdynia

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location status: Recruiting

Location contact

Maciej Stukan

SUB_INVESTIGATOR

Michał Brzeziński

CONTACT

[email protected]

505174271

Michał Brzeziński

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

hrHPV test and cytology

Diagnostic Test

Perfomance of hrHPV test and cytology

Primary outcomes

Anal intraepithelial neoplasm/ anal cancer

Time frame: Just before surgery

Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.

Sponsors and collaborators

Lead sponsor

PCK Marine Hospital in Gdynia

Other

Collaborators

Medical University of Gdansk
National Science Centre, Poland

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Aug 27, 2024
Registry last updated: Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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