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临床试验/NCT05977829
NCT05977829已完成不适用

Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
283
试验地点
1
主要终点
Endometrial cancer rate

研究概览

简要总结

In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.

详细描述

20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies suggest that women who use TAM may also have an increase in the prevalence of uterine sarcomas. In addition, the duration of TAM administration appears to increase the risk of endometrial cancer and uterine sarcoma.

This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without AUB in order to increase the robustness of a still ambiguous literature on the subject. It will estimate the risk of endometrial cancer in women with AUB according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.

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
43 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • In case of AUB: ultrasonographic endometrial thickness >5 mm at transvaginal ultrasound
  • In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities

排除标准

  • severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
  • receiving any other form of pharmacologic therapy

结局指标

主要结局

Endometrial cancer rate

时间窗: 1 month after admission

Endometrial hyperplasia rate

时间窗: 1 month after admission

次要结局

未报告次要终点

研究者

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

Gaetano Riemma

Principal Investigator

University of Campania "Luigi Vanvitelli"

研究点 (1)

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