ClinicalTrials.gg
Sign In
RecruitingNCT06574087Updated Jul 23, 2025

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.

An interventional study of hrHPV test and cytology in HPV-Related Carcinoma and HPV Infection, sponsored by PCK Marine Hospital in Gdynia. Recruiting at 1 site in Poland. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by PCK Marine Hospital in Gdynia · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2023, registered Aug 2024).
  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Sex
Female
01

Study 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.

02

Conditions studied

  • HPV-Related Carcinoma
  • HPV Infection

Keywords

  • anal cancer
  • HPV
  • anal intraepithelial neoplasia
03

In context

Papillomavirus Infections

576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.

This study's planned enrollment of 248 is close to the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

This is the only study on the registry with PCK Marine Hospital in Gdynia as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • HPV related gynecological disease confirmed in histo-pathological examination
  • the posibility to obtain material from gynecological organ and from anal canal
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
248 participants (estimated)

Study arms

  • Active comparator
    HPV- related gynecological disease arm

    Diagnostic Test: hrHPV test and cytology

  • Placebo comparator
    Placebo arm

    Diagnostic Test: hrHPV test and cytology

Interventions

  • Diagnostic testhrHPV test and cytology

    Perfomance of hrHPV test and cytology

06

What researchers measure

Primary outcomes

  1. Anal intraepithelial neoplasm/ anal cancer

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

    Time frame: Just before surgery

07

Study locations

1 of 1 sites recruiting
  • PCK Marine Hospital in Gdynia
    Gdynia, Pomeranian Voivodeship 81-519, Poland
    Recruiting
    • Michał Brzeziński · Contactm.brzezinski@gumed.edu.pl · 505174271
    • Michał Brzeziński · Principal investigator
    • Maciej Stukan · Sub investigator
08

References and documents

Publications

  • 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. PubMed 37445251 ↗
  • Brzezinski 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. PubMed 41296233 ↗

Individual participant data

Plan to share: Undecided — Not yet decided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06574087
Lead sponsor
PCK Marine Hospital in Gdynia
Collaborators
Medical University of Gdansk, National Science Centre, Poland
Responsible party
Michal Brzezinski (MD, PCK Marine Hospital in Gdynia) — Principal investigator
First posted
Aug 27, 2024
Start date
Jan 13, 2023
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Papillomavirus Infections →

Start the discussion