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.
1 other identifier
interventional
248
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2023
CompletedFirst Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
July 23, 2025
August 1, 2024
4 years
August 23, 2024
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anal intraepithelial neoplasm/ anal cancer
Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.
Just before surgery
Study Arms (2)
HPV- related gynecological disease arm
ACTIVE COMPARATORPlacebo arm
PLACEBO COMPARATORInterventions
Perfomance of hrHPV test and cytology
Eligibility Criteria
You may qualify if:
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PCK Marine Hospital in Gdynialead
- Medical University of Gdanskcollaborator
- National Science Centre, Polandcollaborator
Study Sites (1)
PCK Marine Hospital in Gdynia
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Related Publications (2)
Brzezinski M, Stukan M. Anal Cancer and Anal Intraepithelial Neoplasia Risk among Patients Treated for HPV-Related Gynecological Diseases-A Systematic Review. J Clin Med. 2023 Jun 22;12(13):4216. doi: 10.3390/jcm12134216.
PMID: 37445251BACKGROUNDBrzezinski M, Stukan M. Synchronous anal HPV Infection in Patients with HPV-Related Gynaecological Diseases: A Prospective Study. Infect Dis Ther. 2026 Jan;15(1):285-295. doi: 10.1007/s40121-025-01272-6. Epub 2025 Nov 26.
PMID: 41296233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 27, 2024
Study Start
January 13, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
July 23, 2025
Record last verified: 2024-08