NCT02321228进行中（未招募）不适用
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers
University Medical Center Nijmegen21 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
- 试验地点
- 21
- 主要终点
- Menopause-related quality of life
研究概览
简要总结
The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.
详细描述
Eligible women will choose for the innovative or standard risk-reducing option themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
- •Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
- •Childbearing completed
- •Presence of at least one fallopian tube
- •Participants may have a personal history of non-ovarian malignancy
排除标准
- •Postmenopausal status (natural menopause or due to (cancer) treatment)
- •Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
- •Legally incapable
- •Prior bilateral salpingectomy
- •A personal history of ovarian, fallopian tube or peritoneal cancer
- •Evidence of malignant disease at enrollment
- •Treatment for malignant disease at enrollment
- •Inability to read or speak Dutch
- •BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need
结局指标
主要结局
Menopause-related quality of life
时间窗: Up to 5 years after last surgery
Measured by the Greene Climacteric Scale
次要结局
- Surgery-related complications(6 weeks after each surgery)
- Cardiovascular risk factors(Up to 5 years after last surgery)
- Cost-effectiveness of innovative preventive strategy(10 years after last surgery)
- General quality of life(Up to 15 years after last surgery)
- Quality of life related items(Up to 15 years after last surgery)
- Histopathologic findings of removed fallopian tubes and ovaries(6 weeks after each surgery)
- Incidence of cardiovascular diseases(Up to 15 years after last surgery)
- Incidence of breast cancer(Up to 15 years after last surgery)
- Incidence of ovarian cancer(Up to 15 years after last surgery)
研究者
Joanne A. de Hullu, MD, PhD
MD, PhD, gynecologic oncologist, principal clinician
University Medical Center Nijmegen
研究点 (21)
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