Actively Recruiting
Therapeutic Abstention and Surveillance of High-Grade Cervical Lesions (CIN2) in Women Aged 18 to 39
Led by University Hospital, Bordeaux · Updated on 2025-02-10
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the natural regression of cervical intraepithelial neoplasia grade 2 (CIN2) lesions in women aged 18 to 39. This study aims to observe how often CIN2 lesions shrink or improve on their own over two years, as an alternative to the usual treatment of conization. The study is observational and may extend follow-up to four years to better understand long-term outcomes. Women with confirmed CIN2 who meet specific criteria will not receive immediate treatment but will be monitored regularly. This includes clinical exams such as colposcopy and cytology every six months for up to two years, with possible extension to four years. The study focuses on careful surveillance instead of surgical intervention, aiming to reduce risks associated with treatment. Participants will attend regular visits for colposcopic examinations and biopsies if needed, along with HPV viral testing and cytology. Researchers will track lesion regression rates at two and four years and monitor HPV viral expression throughout the follow-up. The study includes safety monitoring and data collection on lesion changes, with participant involvement lasting at least two years and possibly up to four years.
CONDITIONS
Brief Title
Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 18 and 39 years
- Confirmed CIN2 diagnosis by biopsy
- Satisfactory colposcopy showing the junction and lesion clearly
- Affiliated with or beneficiary of a social security scheme
- Provided oral agreement and authorization for data processing
You will not qualify if you...
- Currently pregnant
- Previous conization surgery
- Presence of atypical glandular cells or incidental cancer found during smear
- Prophylactic HPV vaccination
- Active systemic infection needing treatment, history of HIV, or immunodepression
- Long-term corticosteroid or immunosuppressant treatment
- Under legal protection measures such as safeguard of justice
- Non-compliance or inability to follow long-term study requirements properly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who abstain from CIN2 treatment are monitored with cytology and colposcopy, with or without biopsy, every 6 months.
Visits every 6 months for up to 2 years
Duration - Up to 4 years
Participants continue to have follow-up assessments to observe the regression of CIN2 lesions and HPV viral expression for up to 4 years.
Annual visits after 2 years, up to year 4
Trial Site Locations
Total: 1 location
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
J
Jean-Luc Brun, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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