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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorPCK Marine Hospital in Gdynia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

HPV related gynecological disease confirmed in histo-pathological examination

the posibility to obtain material from gynecological organ and from anal canal

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • hrHPV test and cytology

    Diagnostic test

    Perfomance of hrHPV test and cytology

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: HPV- related gynecological disease armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Anal intraepithelial neoplasm/ anal cancer

Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases.

Time frame
Just before surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PCK Marine Hospital in Gdynia

Lead sponsor

Medical University of Gdansk

Collaborator

National Science Centre, Poland

Collaborator