HPV Infection, HPV-Related Carcinoma
Conditions
Keywords
anal cancer, HPV, anal intraepithelial neoplasia
Brief summary
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.
Interventions
DIAGNOSTIC_TESThrHPV test and cytology
Perfomance of hrHPV test and cytology
Sponsors
Medical University of Gdansk
National Science Centre, Poland
PCK Marine Hospital in Gdynia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* HPV related gynecological disease confirmed in histo-pathological examination * the posibility to obtain material from gynecological organ and from anal canal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal intraepithelial neoplasm/ anal cancer | Just before surgery | Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases. |
Countries
Poland
Outcome results
None listed