Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 829
- 试验地点
- 1
- 主要终点
- Incidence of endometrial cancer
研究概览
简要总结
This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.
详细描述
This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.
The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.
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
- 是
入选标准
- •Personal history of breast cancer
排除标准
- •Personal history of other hormonal sensitive cancers
- •Assumption of hormones in the previous 5 years
- •Previous medical assisted reproduction technique
- •Lynch syndrome or BRCA 1/2 mutations
结局指标
主要结局
Incidence of endometrial cancer
时间窗: One year
Evaluation of the incidence of endometrial cancer and atypical hyperplasya
次要结局
- Ultrasonographic soft markers of endometrial pathology(One year)
研究者
Benito Chiofalo
MD, PhD
Regina Elena Cancer Institute