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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HPV-Related Carcinoma HPV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HPV- related gynecological disease arm

Group Type ACTIVE_COMPARATOR

hrHPV test and cytology

Intervention Type DIAGNOSTIC_TEST

Perfomance of hrHPV test and cytology

Placebo arm

Group Type PLACEBO_COMPARATOR

hrHPV test and cytology

Intervention Type DIAGNOSTIC_TEST

Perfomance of hrHPV test and cytology

Interventions

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hrHPV test and cytology

Perfomance of hrHPV test and cytology

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes