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临床试验/NCT06677242
NCT06677242尚未招募不适用

Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月1日最近更新:
适应症

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
Progression-free survival

研究概览

简要总结

Background: Serous endometrial intra-epithelial carcinoma (SEIC) is a rare condition affecting the lining of the uterus. It's a pre-cancerous change that might lead to cancer if not treated. Doctors aren't sure of the best way to manage it because it's so uncommon. A previous study looked at past cases in the Netherlands from 2012 to 2020. This study found that none of the 23 women with SEIC had their cancer spread during surgery, and none had a recurrence in the following three years. This suggests that a simpler surgery might be safe for patients with SEIC.

Methods: Information on disease details from patients who agree to participate in our study will be collected. All participants will fill out online forms and health questionnaires at several points: when they join the study, and again at six months, two years, and five years after their diagnosis. During the years after diagnosis, various details like health status, test results, treatments will be checked in the electronic medical record.

Results: This study is just starting, with the first patients expected to join on January 1, 2025.

Conclusion: A large international study is created to track SEIC patients over time. This will help us learn more about the condition and improve treatment strategies.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Serous endometrial intra-epithelial carcinoma (SEIC).
  • Women older than 18 years of age.
  • Women with understanding of Dutch or English language in reading and writing.

排除标准

  • Diagnosis with a different type of endometrial neoplasm or invasive carcinoma.
  • Previous and/or current treatment for another malignancy (<2 year before diagnosis of SEIC).

结局指标

主要结局

Progression-free survival

时间窗: 5 years

Survival without recurrence of endometrial neoplasm

次要结局

  • Overall survival(5 years)
  • Health-related quality of life(5 years)
  • Adverse events(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciska Slaager

MD, PhD student and resident in gynaecology

Erasmus Medical Center

研究点 (1)

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