NCT06967740 Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
| NCT ID | NCT06967740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nikola Janovska |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-11-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Lukas Rob, Prof., MUDr., Csc.
PRINCIPAL INVESTIGATOR
Vascular surgery, University hospital Královské Vinohrady, Prague
Frequently Asked Questions
Who can join the NCT06967740 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 46 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06967740 currently recruiting?
Yes, NCT06967740 is actively recruiting participants. Contact the research team at lukas.rob@fnkv.cz for enrollment information.
Where is the NCT06967740 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06967740 clinical trial?
NCT06967740 is sponsored by Nikola Janovska. The principal investigator is Lukas Rob, Prof., MUDr., Csc. at Vascular surgery, University hospital Královské Vinohrady, Prague. The trial plans to enroll 200 participants.
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