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

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.

Recruiting

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Key information

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia (CIN) Conservative Management Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Risk Factors Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location status: Recruiting

Location contact

Lukas Rob, Prof., MUDr., Csc.

CONTACT

[email protected]

+420 296472368

Nikola Janovska, MUDr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping

Time frame: 2 year follow up

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
To evaluate spontaneous regression/progression over a 2-year period according to methylation results

Time frame: 2 year follow up

Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2)
o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus

Time frame: 2 year follow up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lukas Rob, Prof. MUDr., Csc.

CONTACT

[email protected]

+420 296472368

Sponsors and collaborators

Lead sponsor

Nikola Janovska

Other Gov

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2029
First posted: May 13, 2025
Registry last updated: Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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