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The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women.
Research Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unvaccinated | Without adjuvant vaccination for HPV | ||
| Vaccinated | Adjuvantly vaccinated against HPV with Gardasil-9 |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping | Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping | 2 year follow up |
| To evaluate spontaneous regression/progression over a 2-year period according to methylation results | Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2) | 2 year follow up |
| o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus | Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to CinTec plus test - mmunohistochemical marker utilizing two proteins - p16 and Ki67 | 2 year follow up |
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Inclusion Criteria:
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Females with HG precancerous lesions of the cervix.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Rob, Prof. MUDr., Csc. | Contact | +420 296472368 | lukas.rob@fnkv.cz |
| Name | Affiliation | Role |
|---|---|---|
| Lukas Rob, Prof., MUDr., Csc. | Vascular surgery, University hospital Královské Vinohrady, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Kralovske Vinohrady | Recruiting | Prague | 10034 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29762428 | Background | Lee MH, Finlayson SJ, Gukova K, Hanley G, Miller D, Sadownik LA. Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women. J Low Genit Tract Dis. 2018 Jul;22(3):212-218. doi: 10.1097/LGT.0000000000000399. | |
| 27469988 | Background | Kyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kalliala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633. doi: 10.1136/bmj.i3633. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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cytology, cervical biopsy
| 25991420 | Background | Depuydt CE, Jonckheere J, Berth M, Salembier GM, Vereecken AJ, Bogers JJ. Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections. Cancer Med. 2015 Aug;4(8):1294-302. doi: 10.1002/cam4.473. Epub 2015 May 20. |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |