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临床试验/NCT04057924
NCT04057924招募中不适用

Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
rate of spontaneous regression of CIN2 at 2 years

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

结局指标

主要结局

rate of spontaneous regression of CIN2 at 2 years

时间窗: 2 years

Rate of spontaneous regression of CIN2 at 2 years, either complete (disappearance of the lesion) or partial (\<lesions of low grade LSIL).

次要结局

  • rate of regression of CIN2 at 4 years(4 years)
  • HPV viral expression(1, 2, 3 and 4 years)
  • 4-year regression rate of CIN2 that persisted for 2 years(1, 2, 3 and 4 years)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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