Prospective Research of Outcomes After Salpingo-oophorectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.
研究概览
简要总结
PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management. The investigators will compare the change in cardiovascular health, bone health, sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not undergo RRSO.
The investigators hypothesis is that women who undergo a premature surgical menopause induced by RRSO have worse cardiovascular health and bone health compared with women who do not undergo RRSO.
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
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BRCA mutation 1/2 or "Variant suspected deleterious" mutation.
- •Age 35-50 years
- •Able to undergo RRSO
- •Speaks English
- •Able to give informed consent
排除标准
- •Prior history of bilateral oophorectomy
- •BRCA 1/2 deleterious mutation
- •Plans to move out of geographic region in next 3 years
- •Unable to travel to study visits
结局指标
主要结局
Change from baseline in risk of cardiovascular disease and osteoporosis at 36 months.
时间窗: Baseline to 36 Months
We will use dual-energy x-ray absorptiometry (DEXA) scan results and Intima-media thickness of the carotid artery (IMT) testing to assess changes in bone mineral density and carotid artery intima media thickness, respectively.
Change in baseline sexual functioning and quality of life at 36 months.
时间窗: Baseline to 36 Months
We will use standard questionnaires to assess changes in overall quality of life and sexual function.
次要结局
未报告次要终点