RecruitingNCT06967740

Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs


Sponsor

Nikola Janovska

Enrollment

200 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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: * Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk). * Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients. * Evaluate spontaneous regression/progression over two years based on methylation results. * Assess spontaneous regression/progression over two years based on CinTec plus results.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 46 Years

Inclusion Criteria6

  • Informed Consent
  • cervical biopsy - HG lesion
  • Age: 18-46 years
  • colposcopicaly visible transformation zone
  • HPV: Unvaccinated
  • cytology all except AIS, adenocarcinoma, squamous cell carcinoma, AGC NEO

Exclusion Criteria5

  • cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
  • immunosuppression
  • active autoimmune disease
  • history of cervical cryodestruction
  • HPV vaccinated prior to start of the study

Locations(1)

University Hospital Kralovske Vinohrady

Prague, Czechia

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NCT06967740


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