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| Name | Class |
|---|---|
| Medical University of Gdansk | OTHER |
| National Science Centre, Poland | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV- related gynecological disease arm | Active Comparator |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hrHPV test and cytology | Diagnostic Test | Perfomance of hrHPV test and cytology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anal intraepithelial neoplasm/ anal cancer | Number of Participants with anal intraepithelial neoplasm/ anal cancer among patients with HPV-related gynecological diseases. | Just before surgery |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PCK Marine Hospital in Gdynia | Recruiting | Gdynia | Pomeranian Voivodeship | 81-519 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37445251 | Background | Brzezinski M, Stukan M. Anal Cancer and Anal Intraepithelial Neoplasia Risk among Patients Treated for HPV-Related Gynecological Diseases-A Systematic Review. J Clin Med. 2023 Jun 22;12(13):4216. doi: 10.3390/jcm12134216. | |
| 41296233 | Derived | Brzezinski M, Stukan M. Synchronous anal HPV Infection in Patients with HPV-Related Gynaecological Diseases: A Prospective Study. Infect Dis Ther. 2026 Jan;15(1):285-295. doi: 10.1007/s40121-025-01272-6. Epub 2025 Nov 26. |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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