Actively Recruiting
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.
Led by PCK Marine Hospital in Gdynia · Updated on 2025-07-23
248
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
P
PCK Marine Hospital in Gdynia
Lead Sponsor
M
Medical University of Gdansk
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HPV related gynecological disease confirmed in histo-pathological examination
- The possibility to obtain material from gynecological organ and from anal canal
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
PCK Marine Hospital in Gdynia
Gdynia, Pomeranian Voivodeship, Poland, 81-519
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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