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 type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 248 (estimated) |
| Sponsor | PCK Marine Hospital in Gdynia Academic / other |
| Locations | 1 site (Gdynia, Pomeranian Voivodeship) |
| Status | Recruiting |
| Started | January 13, 2023 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT06574087 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
15-valent HPV vaccine for people aged 9–45 in China.
This trial will test whether a 15‑valent HPV vaccine is safe and prompts immune responses in people aged 9–45.
-
Risk of cervical cancer after HPV detection in healthy women
This study tests how likely it is for cervical cancer to develop after different HPV detection patterns in healthy women who undergo HPV-based screening.
-
Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes
This trial tests whether nightly Dysplasix™ vaginal suppositories can clear high‑risk HPV and help mild cervical cell changes (ASC‑US or LSIL) in adult women.
-
At-home HPV self-collection kits for cervical cancer screening
We are testing different ways to give at-home HPV self-collection kits to under-screened people aged 25–65 to see if more of them complete cervical cancer screening and follow-up.
-
Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV
This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.
-
HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer
This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.