Study on Managing High-Risk HPV and Precancerous Cervical Lesions in Women Aged 18 to 46
Led by Nikola Janovska · Updated on 2025-07-31
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to develop clinical guidelines for managing women who test positive for high-risk human papillomavirus HPV HR and have cervical lesions. The study focuses on women aged 18 to 46 and evaluates how HPV HR testing can be integrated into screening programs for women aged 35, 45, and 55. The study also compares outcomes for women vaccinated against HPV with Gardasil-9 and those who are unvaccinated.
Participants are grouped based on HPV vaccination status those not vaccinated against HPV and those who received the Gardasil-9 vaccine. The study observes spontaneous regression or progression of cervical lesions over a two-year period. This is assessed using HPV HR genotyping, viral load, methylation results, and CinTec plus testing.
During the study, participants undergo regular cervical biopsies, colposcopy, and HPV testing to monitor lesion changes. Researchers evaluate outcomes such as lesion regression or progression over two years. The study tracks these results without providing active treatment and includes follow-up assessments to better understand the natural course of cervical lesions in both vaccinated and unvaccinated women.
CONDITIONS
Brief Title
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Research Team
L
Lukas Rob, Prof. MUDr., Csc.
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Cytology showing AIS, AGC NEO, adenocarcinoma, or squamous cell carcinoma
Having immunosuppression
Active autoimmune disease
History of cervical cryodestruction
HPV vaccination before the start of the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - 2 years
Participants are monitored over a 2-year period to observe spontaneous regression or progression of precancerous lesions based on HPV genotyping, methylation results, and CinTec plus assessments.
Regular visits during the 2-year period
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Phase 12a Study of 177Lu-BetaBart, a Radiolabeled Anti-B7-H3 Antibody, for Safety and Early Effectiveness in Adults with Relapsed or Metastatic Solid Tumors
Evaluating 18F-T2 PETCT Imaging for Detecting Tumors with High CAIX Levels in Adults
Phase 12 Study of MDNA11, a Beta-only IL-2 Therapy, Alone or With Pembrolizumab for Advanced Solid Tumors
A Phase 3 Study Testing Sacituzumab Tirumotecan With Pembrolizumab, With or Without Bevacizumab, Compared to Standard Care for Women With Advanced or Recurrent Cervical Cancer
Safety and Feasibility Study of PVX7 Immunotherapy for Advanced Cervical Cancer in Women Who Completed Primary Treatment
Study on Cervical and Endometrial Cancer in Women Aged 20 to 75
Phase I Study of Cardunizumab Combined with Pulsed Low-dose Rate Radiation for Recurrent Lung, Esophageal, and Cervical Cancers
Study on Using Pre-treatment Tumor Biopsies to Predict Response to PD-1PD-L1 Immunotherapy in Various Cancers
Phase 1 Study of NRM-823 Alone and Combined With Checkpoint Inhibitors for Advanced or Metastatic Refractory Solid Tumors
Phase 12 Study of TER-2013 Alone or with Fulvestrant in Adults with Advanced Solid Tumors Having AKTPI3KPTEN Pathway Changes
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections.
Christophe E Depuydt, Jef Jonckheere, Mario Berth...
Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis.
Maria Kyrgiou, Antonios Athanasiou, Maria Paraskevaidi...