Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: abstention from CIN2 treatment and surveillance for at least 2 years.
- Who it may be relevant to
- Registry conditions: HPV Infection, Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 treatment of reference (conization) with a possible extension to 4 years
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. These are women under 30 years old, with a small lesion in colposcopy, without any sign of invasion, with a squamocolumnar junction seen. These women must accept the principle of regular monitoring by cytology and colposcopy +/- biopsy every 6 months for a maximum of 2 years. HSIL group 2 histological entities CIN2 and CIN3. It is recognized that CIN2 are associated with CIN1 and CIN3 biology whose diagnosis is the result of the subjectivity of colposcopy allowing cervical biopsy and the variability of pathological interpretation due to poor reproducibility of histological diagnosis. CIN2 regress spontaneously in more than 50% of cases at 1 year, either completely (no lesion) or partially (LSIL low grade lesions). No invasive lesions are diagnosed over 2-year observation periods. Among the clinical, pathological and virological criteria, only the initial HPV genotyping seems to have a prognostic influence. There is therefore no strong scientific argument for routine conization in a woman over 30 years of age with a CIN2 lesion extended over more than two quadrants. In addition, conization is associated with an obstetrical risk (prematurity) and post-therapeutic colposcopic cervical stenosis complicates subsequent monitoring in case of abnormal smears. These considerations encourage the extension of the indications of abstention monitoring in the management of women with CIN2 wishing to procreate with an extension of the age to 39 year old, with no limit of size of the lesion and to satisfactory colposcopy
Interventions
- Other abstention from CIN2 treatment and surveillance for at least 2 years
Non-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
Primary outcome measures
- rate of spontaneous regression of CIN2 at 2 years [Time frame: 2 years]
Secondary outcome measures (3)
- rate of regression of CIN2 at 4 years [Time frame: 4 years]
- 4-year regression rate of CIN2 that persisted for 2 years [Time frame: 1, 2, 3 and 4 years]
- HPV viral expression [Time frame: 1, 2, 3 and 4 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- CHU Bordeaux — Bordeaux
Identifiers
NCT: NCT04057924 · CHUBX 2019/03