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.

PCK Marine Hospital in Gdynia

Status: Enrolling

Conditions: HPV-Related Carcinoma; HPV Infection

Treatments: Diagnostic Test: hrHPV test and cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT06574087

PCK01

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups, including a placebo group

HPV- related gynecological disease arm

Active Comparator group

Treatment:

Diagnostic Test: hrHPV test and cytology

Placebo arm

Placebo Comparator group

Treatment:

Diagnostic Test: hrHPV test and cytology