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临床试验/NCT07804745
NCT07804745进行中(未招募)不适用

Fertility Decision and Outcomes in Young Women With Breast Cancer

Second Affiliated Hospital, Zhejiang University, School of Medicine3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
3
主要终点
Childbearing after breast cancer diagnosis

研究概览

简要总结

This observational study is to learn about the fertility outcomes and decision after breast cancer diagnosis, and the current status of fertility consultation and decision support in young women diagnosed with breast cancer in China.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female breast cancer patients, aged 18-40 years at diagnosis.
  • •Treated at the three participating hospitals between 1 January 2013 and 31 December
  • •Complete clinical documentation available in the electronic medical record system.
  • •Had no child before cancer diagnosis.

排除标准

  • •Prior reproductive compromise (surgical or diagnostic infertility or pre-existing infertility factors) before cancer diagnosis.
  • •Presented with de novo stage IV (metastatic) disease.
  • •Had a history of other malignancies.
  • •Patients who refuse to participate or cannot be contacted for follow-up.

研究组 & 干预措施

Control Group (Childbearing after diagnosis)

Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had at least one live birth after diagnosis.

干预措施: No intervention (observational study) (Other)

Case Group (No childbearing after diagnosis)

Patients diagnosed with breast cancer who had no live birth prior to diagnosis but had no live birth after diagnosis.

干预措施: No intervention (observational study) (Other)

结局指标

主要结局

Childbearing after breast cancer diagnosis

时间窗: Up to 2026

We will follow up with patients who had not given birth before their cancer diagnosis, to establish whether they had given birth by the end of follow-up. It will be assessed by patient self-report during follow-up and available medical records. The outcome will be recorded as a binary variable (yes/no).

次要结局

  • Fertility preservation measures uptake(up to 2026)
  • Multidisciplinary collaboration involvement(up to 2026)

研究者

发起方
Second Affiliated Hospital, Zhejiang University, School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (3)

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