降低风险的输卵管切除术和延迟卵巢切除术作为高风险女性降低风险的输卵管卵巢切除术的替代方案，以评估预防的安全性——美国队列研究
This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
研究概览
地位
详细说明
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.
PRIMARY OBJECTIVE:
To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
SECONDARY OBJECTIVE:
Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.
EXPLORATORY OBJECTIVE:
Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Roni Wilke, MD
- 电话号码：(713) 822-4502
- 邮箱：rnitecki@mdanderson.org
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60637
- 招聘中
- University of Chicago
-
接触：
- Kathryn Mills, MD
- 邮箱：kmills6@bsd.uchicago.edu
-
首席研究员：
- Kathryn Mills, MD
-
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Massachusetts
-
Boston、Massachusetts、美国、02215
- 招聘中
- Dana Farber Cancer Institute
-
接触：
- Colleen Feltmate
- 邮箱：cfeltmate@bwh.harvard.edu
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首席研究员：
- Colleen Feltmate
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic
-
首席研究员：
- Jamie N Bakkum-Gamez, MD
-
接触：
- Jamie N Bakkum-Gamez, MD
- 邮箱：bakkum.jamie@mayo.edu
-
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Missouri
-
St Louis、Missouri、美国、63130
- 招聘中
- WU St Louis
-
首席研究员：
- Andrea Hagemann, MD
-
接触：
- Andrea Hagemann, MD
-
-
New York
-
New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center
-
首席研究员：
- Kara Long-Roche, MD
-
接触：
- Kara Long-Roche, MD
- 邮箱：longrock@mskcc.org
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New York、New York、美国、10029
- 招聘中
- Mount Sinai Health System
-
首席研究员：
- Stephanie Blank, MD
-
接触：
- Stephanie Blank, MD
- 邮箱：Stephanie.Blank@mountsinai.org
-
-
North Carolina
-
Durham、North Carolina、美国、27708
- 招聘中
- Duke University
-
接触：
- Haley Moss, MD
- 邮箱：haley.moss@duke.edu
-
首席研究员：
- Haley Moss, MD
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- 招聘中
- University of Pennsylvania
-
接触：
- Sarah Kim, MD
- 邮箱：Sarah.Kim@pennmedicine.upenn.edu
-
首席研究员：
- Sarah Kim, MD
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- M D Anderson Cancer Center
-
接触：
- Roni Wilke, MD
- 电话号码：713-822-4502
- 邮箱：rnitecki@mdanderson.org
-
Houston、Texas、美国、77026
- 招聘中
- Lyndon Baines Johnson General
-
接触：
- Roni Wilke, MD
- 邮箱：rnitechi@mdanderson.org
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首席研究员：
- Roni Wilke, MD
-
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Washington
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Seattle、Washington、美国、98195
- 招聘中
- University of Washington
-
首席研究员：
- Barbara Norquist, MD
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接触：
- Barbara Norquist, MD
- 邮箱：bnorquis@uw.edu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
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Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
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Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.
- The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
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No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
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Presence of at least one fallopian tube.
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Participants may have a personal history of non-ovarian malignancy.
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Informed consent must be obtained and documented.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-
Postmenopausal status (natural menopause or due to (cancer) treatment)
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
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Wish for second stage RRO within two years after RRS (if clear at enrollment)
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Legally incapable
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Prior bilateral salpingectomy
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A personal history of ovarian, fallopian tube, or peritoneal cancer
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Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Risk-Reducing Salpingectomy-RRS
Can help to lower the risk of ovarian cancer with a delayed removal of 1. |
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure |
|
其他：Risk-Reducing Oophorectomy-RRO
Can help to lower the risk of ovarian cancer removing both fallopian tubes. |
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure |
|
其他：Risk-Reducing Salpingo-Oophorectomy-RRSO
Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO) |
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
评估创新治疗方案（延迟RRO的RRS）相较于标准治疗方案（RRSO）在BRCA1/2基因种系突变携带者高级别浆液性（卵巢）癌发病率方面的非劣效性。
大体时间：直至研究完成，平均15年
|
直至研究完成，平均15年
|
合作者和调查者
调查人员
- 首席研究员：Roni Wilke, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.