Assessing screening methods for anal intraepithelial neoplasia in HPV patients
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.
NA · PCK Marine Hospital in Gdynia · NCT06574087
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Sex | Female |
| Sponsor | PCK Marine Hospital in Gdynia (other) |
| Locations | 1 site (Gdynia, Pomeranian Voivodeship) |
| Trial ID | NCT06574087 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there have been studies on HPV and anal cancer, this specific approach to screening AIN in HPV patients is relatively novel.
Eligibility criteria
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 this trial is running
Gdynia, Pomeranian Voivodeship
- PCK Marine Hospital in Gdynia — Gdynia, Pomeranian Voivodeship, Poland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HPV-Related Carcinoma, HPV Infection, anal cancer, HPV, anal intraepithelial neoplasia