Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women.
Marette H Lee, Sarah J Finlayson, Ksenia Gukova...
https://pubmed.ncbi.nlm.nih.gov/29762428Actively Recruiting
Age: 18Years - 46Years
FEMALE
ID06967740
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Led by Nikola Janovska · Updated on 2025-07-31
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years - 46Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Have a cervical biopsy showing a high-grade lesion
- Female aged 18 to 46 years
- Visible transformation zone on colposcopy
- Not vaccinated against HPV before the study
- Cytology results excluding AIS, adenocarcinoma, squamous cell carcinoma, and AGC NEO
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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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
Trial Site Locations
Total: 1 location
1
University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
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Research Team
L
Lukas Rob, Prof. MUDr., Csc.
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
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Published Research Related To This Trial
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...
https://pubmed.ncbi.nlm.nih.gov/27469988Serial 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...
https://pubmed.ncbi.nlm.nih.gov/25991420