Status:
RECRUITING
Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
HPV Infection
Cervical Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the ...
Detailed Description
The INCa recommendations of December 2016 propose the destruction or abstention-monitoring of high-grade histological cervical lesions (HSIL) as an alternative to conization under certain conditions. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04057924
Start Date
August 23 2019
End Date
September 1 2029
Last Update
February 10 2025
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France