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临床试验/NCT07394413
NCT07394413尚未招募不适用

Surgical Handling of Fertility-preserving Treatments for Cervical Adenocarcinomas

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Recurrence rate

研究概览

简要总结

Despite a growing body of literature on the subject, there is still uncertainty regarding direct comparisons between different conservative surgical techniques for cervical adenocarcinomas. In particular, it remains unclear whether fertility-sparing surgery for cervical adenocarcinomas - characterized by skip lesions - can ensure optimal disease control while achieving adequate obstetric outcomes.

For this reason, a systematic review and meta-analysis of the literature, along with an analysis of our center's data, is warranted. This approach will allow a critical, comparative evaluation of the efficacy of the different techniques (conization, simple trachelectomy, and radical trachelectomy) and the identification of prognostic factors to guide therapeutic choice.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Adult women of reproductive age with a diagnosis of cervical adenocarcinoma
  • Undergoing fertility-sparing surgery
  • Minimum 12-month follow-up
  • Signed informed consent

排除标准

  • Histotypes other than cervical adenocarcinoma
  • Undergoing radical surgery
  • Follow-up less than 12 months

结局指标

主要结局

Recurrence rate

时间窗: 5 years

The recurrence rate is defined as the proportion of patients who develop disease recurrence confirmed by imaging or histopathologic evaluation after FSS.

Disease free survival

时间窗: 5 years

Disease-free survival is defined as the time from surgery until the first documented recurrence.

Overall survival

时间窗: 5 years

Overall survival is measured as the time from surgery to death from any cause,

次要结局

  • pregnancy rate(5 years)
  • live birth rate(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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