Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Launched by NIKOLA JANOVSKA · May 4, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how to best manage women with certain precancerous changes in the cervix, particularly those who are positive for high-risk HPV (a virus linked to cervical cancer). The researchers aim to create guidelines that can help doctors treat these women more effectively by studying how these lesions may change over time. They will also look into how factors like HPV testing and vaccination influence the chances of these lesions getting better or worse.
To participate in this study, women between the ages of 18 and 46 who have had a cervical biopsy showing a high-grade lesion can join, provided they have not been vaccinated against HPV. Participants will monitor their condition over two years, and the study will help gather important information that could improve care for women at risk of cervical cancer. If you decide to take part, you’ll have the opportunity to contribute to research that may benefit many others in the future.
Gender
FEMALE
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
About Nikola Janovska
Nikola Janovska is an innovative clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through rigorous and ethical trial management. With a focus on developing novel therapies across various therapeutic areas, the organization is committed to ensuring the highest standards of scientific integrity and regulatory compliance. Leveraging a team of experienced professionals, Nikola Janovska collaborates with healthcare institutions and regulatory bodies to streamline the clinical development process, fostering an environment of transparency and collaboration. Their mission is to contribute to the evolution of healthcare by bringing safe and effective treatments to market efficiently and responsibly.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prague, , Czech Republic
Patients applied
Trial Officials
Lukas Rob, Prof., MUDr., Csc.
Principal Investigator
University Hospital Kralovske Vinohrady
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported