Conservative Management in Patients Diagnosed With Grade 2 or Grade 3 CIN
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- H-SIL Resolution
研究概览
简要总结
Consecutive inclusion and collection of information for all women attending the Cervical Disease Unit with an histological diagnosis of grade 2 or grade 3 CIN during the last 5 years, from January 2012 to December 2016, which meet the inclusion criteria, have voluntarily manifested pregnancy intendedness and had a minimum follow-up time of 2 years and a maximum of 7.
The aim is to evaluate whether the HSIL resolution rates (CIN 2 or CIN 3) are sufficient to support conservative management.
详细描述
Follow-up is performed every 4 months with colposcopy, cytology and biopsies. Colposcopy and cytology are performed for all control subjects. The need for biopsy is established according to the colposcopy exam findings to confirm H-SIL or cervical cancer. Follow-up is spaced every 6 months if the cytology and biopsy results indicate L-SIL / ASCUS in agreement with the colposcopic image. HPV tests are performed every 8-12 months. This strategy is maintained until the resolution of the H-SIL.
The conservative management stops if the H-SIL lesion persists after 24 months of follow-up, if the inclusion criteria are no longer met or if the exclusion ones are met.
Inclusion and exclusion criteria are reviewed at each visit and the conservative management ceases in case the patient decides to undergo conization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reproductive age and willing to get pregnant in the future
- •Acceptance of conservative management
- •Commitment to study visits.
- •Colposcopy with zone of transformation (ZT) type 1 or 2 (Unio esco-columnar totally visible) with image compatible with H-SIL and visible in its entirety.
排除标准
- •Pregnant women
- •Immunosuppression for human immunodeficiency virus (HIV) or iatrogenic type
- •suspicion or diagnosis of Glandular Cell Atipia (ACG), Adenocarcinoma in situ (AIS) or cervical cancer (CC)
- •Provided that inclusion criteria are not met
结局指标
主要结局
H-SIL Resolution
时间窗: 24 months
In cases where H-SIL (cytologic, histological and colposcopic) is no longer detected during follow-up. Include the strict resolution, indulgent resolution and regression
H-SIL Regression
时间窗: 24 months
H-SIL is not detected, but with a low grade cytological, histologic or colposcopic lesion
次要结局
- Factors probably related to the resolution(24 months)
- Lenient resolution(24 months)
- Strict resolution(24 months)
- Conization surgery(24 months)