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临床试验/NCT03961178
NCT03961178Unknown不适用

Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study

Lei Li1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10,000
试验地点
1
主要终点
The cumulative incidences of precancerous lesions or cancers

研究概览

简要总结

This study is to investigate the oncologic and obstetric outcomes in patients with conization for uterine cervical lesions from January 1, 2000 to January 1, 2019 in Peking Union Medical College Hospital.

The primary objectives consist of following:

  1. The cumulative incidences of precancerous lesions and cancers of lower genital tract in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009)
  2. The cumulative pregnancy rates in patients sparing the fertility

The secondary objectives consist of following:

  1. The effects of surgical protocols (modified Sturmdorf method and "8" figure suture) and energy equipment (cold knife and monopolar electrical cautery) on the oncologic and obstetric outcomes, and on the histological components.
  2. A full description of histological components of the conization specimens
  3. The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Accepting conization in the study center
  • Aged 18 years or older

排除标准

  • Not meeting any of the inclusion criteria

结局指标

主要结局

The cumulative incidences of precancerous lesions or cancers

时间窗: Five years

The cumulative incidences of precancerous lesions and cancers of lower genital track in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009)

The cumulative pregnancy rates

时间窗: Five years

The cumulative pregnancy rates in patients sparing the fertility

次要结局

  • The cumulative live birth rates(Five years)
  • The virus outcomes after conization(Five years)
  • The cumulative pregnancy loss rates(Five years)
  • The cytological results after conization(Five years)

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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