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

Nikola Janovska

Status: Enrolling

Conditions: Cervical Intraepithelial Neoplasia (CIN); Conservative Management; Risk Factors; Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06967740

EKVP/51/2024

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 46 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

200 participants in 2 patient groups

Unvaccinated

Description:

Without adjuvant vaccination for HPV

Vaccinated

Description:

Adjuvantly vaccinated against HPV with Gardasil-9