Monitoring high-grade cervical lesions without immediate surgery
Official title: Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
Run by University Hospital, Bordeaux · NCT04057924 · Data updated 2026-11-12
This study is testing if young women with certain cervical lesions can safely avoid surgery by just being monitored over two years to see if their condition improves on its own.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | August 23, 2019 |
| Main results expected | September 1, 2029 |
| Study ends | September 1, 2029 |
| Registry record updated | February 10, 2025 |
| Trial ID | NCT04057924 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 to 39 with confirmed CIN2 lesions and satisfactory colposcopy results.
✕Probably not a fit
Patients who are pregnant, have a history of conization, or present with atypical cells or cancer are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the rate of spontaneous regression of cervical intraepithelial neoplasia grade 2 (CIN2) in women aged 18 to 39 over a two-year follow-up period. Participants will undergo regular monitoring through cytology and colposcopy, with the possibility of extending the observation period to four years. The study aims to assess whether abstaining from surgical treatment, such as conization, is a viable alternative for certain patients with CIN2 lesions. The research is based on recommendations that suggest monitoring may be effective and safer than immediate surgical intervention for young women with specific criteria.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries in young women while effectively monitoring cervical health.
How similar studies have gone: Previous studies have indicated that a significant percentage of CIN2 lesions may regress spontaneously, suggesting that this monitoring approach could be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * CIN2 confirmed by biopsy, age between 18 and 39 years, * satisfactory colposcopy identifying the junction and the lesion, * affiliated person or beneficiary of a social security scheme, * having given their oral agreement and authorization to the processing of their data. Exclusion Criteria: * Pregnancy in progress, * history of conization, * atypical or atypical glandular cells or cancer incidentally discovered during smear, * prophylactic vaccination against HPV, * active systemic infection requiring treatment, history of HIV infection, congenital or acquired immunodepression, * long-term treatment with corticosteroids or immunosuppressants, placement under safeguard of justice, * non-compliance with protocol requirements, in particular a supposed lack of compliance with long-term follow-up
Where it's running
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CHU Bordeaux
Bordeaux, France Recruiting
Study contacts
- Study coordinator: Jean-Luc Brun, MD, PhD
- Email: jean-luc.brun@chu-bordeaux.fr
- Phone: 335 56 79 59 85
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.