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NCT06967740Recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
4 May 2025
Start date
1 Nov 2024
Primary completion date
Dec 2028
Lead sponsor
Nikola Janovska
NCT number
NCT06967740

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 1 Nov 2024 to the primary completion date, Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • HPV vaccinated prior to start of the study

Other illness

  • active autoimmune disease
  • history of cervical cryodestruction

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to 46 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Kralovske Vinohrady
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.