Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial
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
- 否
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
Gaetano Riemma
Principal Investigator
University of Campania "Luigi Vanvitelli"
