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

Last updated: May 4, 2025
Sponsor: Nikola Janovska
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Human Papilloma Virus (Hpv)

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT06967740
EKVP/51/2024
  • Ages 18-46
  • Female

Study Summary

The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR 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 results.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma

  • immunosuppression

  • active autoimmune disease

  • history of cervical cryodestruction

  • HPV vaccinated prior to start of the study

Study Design

Total Participants: 200
Study Start date:
November 01, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • University Hospital Kralovske Vinohrady

    Prague, 10034
    Czech Republic

    Active - Recruiting

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