Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hrHPV test and cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- HPV- related gynecological disease arm
- interventionNames
- Diagnostic Test: hrHPV test and cytology
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- interventionNames
- Diagnostic Test: hrHPV test and cytology
Primary outcomes (1)
- measure
- Anal intraepithelial neoplasm/ anal cancer
- timeFrame
- Just before surgery
- description
- Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * HPV related gynecological disease confirmed in histo-pathological examination * the posibility to obtain material from gynecological organ and from anal canal
References
Publications (2)
- BACKGROUNDBrzezinski 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 37445251
- DERIVEDBrzezinski 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 41296233