HPV-Related CarcinomaNCT06574087
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.
A study testing hrHPV test and cytology in people with HPV-Related Carcinoma and HPV Infection, run by PCK Marine Hospital in Gdynia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-Related Carcinoma, HPV Infection
- What is being tested?
- hrHPV test and cytology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 sitePoland
- Study dates
- 13 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
PCK Marine Hospital in Gdynia
Gdynia, Pomeranian Voivodeship, 81-519
Michał Brzeziński, 505174271, m.brzezinski@gumed.edu.pl
Michał Brzeziński
About this study
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
- HPV-Related Carcinoma, HPV Infection
- Being tested
- hrHPV test and cytology
- Keywords
- anal cancer, HPV, anal intraepithelial neoplasia
- Medical subject headings
- Papillomavirus Infections, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hrHPV test and cytologyDiagnostic test
Perfomance of hrHPV test and cytology
| Study group | Role | What they receive |
|---|---|---|
| HPV- related gynecological disease arm | Active comparator | Not described Receives: Diagnostic Test: hrHPV test and cytology |
| Placebo arm | Placebo comparator | Not described Receives: Diagnostic Test: hrHPV test and cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal intraepithelial neoplasm/ anal cancer
Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.
Measured: Just before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start13 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HPV-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PCK Marine Hospital in Gdynia
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk, National Science Centre, Poland
- Responsible party
- Principal investigator, Michal Brzezinski, PCK Marine Hospital in Gdynia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574087
- Sponsor's protocol ID
- PCK01
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
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 37445251Brzezinski 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06574087
- Acronym / sponsor ID
- PCK01
- Conditions
- HPV-Related Carcinoma, HPV Infection
- Keywords
- anal cancer, HPV, anal intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- PCK Marine Hospital in GdyniaUniversity, hospital or other
- Collaborators
- Medical University of Gdansk, National Science Centre, Poland
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV- related gynecological disease arm | Active comparator | Diagnostic Test: hrHPV test and cytology |
| Placebo arm | Placebo comparator | Diagnostic Test: hrHPV test and cytology |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hrHPV test and cytologyPerfomance of hrHPV test and cytology | Diagnostic test | HPV- related gynecological disease arm, Placebo arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 37445251Brzezinski 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.
- Derived from this study: PubMed 41296233Brzezinski 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.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hrHPV test and cytology in people with HPV-Related Carcinoma and HPV Infection, run by PCK Marine Hospital in Gdynia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal intraepithelial neoplasm/ anal cancer (time frame: Just before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.