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临床试验/NCT03738969
NCT03738969Unknown不适用

Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer

Lei Li1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2018年11月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pathological confirmed as uterine cervical cancer
  • Having definite clinical information
  • Having received radical hysterectomy or trachelectomy

排除标准

  • Not satisfying any of the inclusion criteria

结局指标

主要结局

Progression-free survival

时间窗: Five years

Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse

次要结局

  • Overall survival(Five years)
  • Disease-free survival(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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