Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk
2010年10月8日 更新者：Memorial Sloan Kettering Cancer Center
We are inviting you to participate in a study of how people who have had genetic counseling for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of passing increased risk onto one's children.
We would also like feedback from patients who have been to our clinic in the past on the best ways to talk about PGD and PND during genetic counseling sessions.
We are seeking both the opinions of people who are interested in these technologies and those who are not.
It does not matter whether you have heard of PGD or PND before - you can still participate.
Your past experience with genetic counseling is valuable to us in deciding how to communicate this information during sessions.
研究概览
研究类型
观察性的
注册 (实际的)
34
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New York
-
New York、New York、美国、10065
- Memorial Sloan-Kettering Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 39年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Prospective participants will be recruited through the MSKCC clinics that serve high-risk patients (e.g.
Clinical Genetics Service, Special Surveillance Breast Program, etc.)
描述
Inclusion Criteria:
- Females and males who are carriers of deleterious mutations in the genes BRCA1 or BRCA2.
Over age 18 and:
- For women, less than 43
- For men, less than 50.
- Received genetic testing and counseling for BRCA.
- Fluent in English.
Exclusion Criteria:
- Patients who are currently under treatment (chemotherapy, radiation)
- Individuals who refuse to discuss reproductive issues.
- Unable to give informed consent due to physical, cognitive, or psychiatric disability
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
1
25 female and 5 male BRCA carriers
|
You will be asked to make a one-time visit to MSKCC.
At that research visit, you will be asked to complete a short questionnaire about your knowledge of various reproductive technologies relevant to individuals at hereditary risk.
Then you will watch a short presentation about these reproductive technologies and complete a second brief questionnaire to assess your understanding of the presentation.
Afterwards, you will meet with an interviewer one-on-one for about one hour, during which time you may share your thoughts and feelings about the use of these reproductive technologies.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To explore the attitudes of BRCA1/2 mutation carriers about PGD/PND, most notably benefits and drawbacks, as well as ethical and emotional considerations;
大体时间：conclusion of study
|
conclusion of study
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To elicit opinions from patients who have previously undergone BRCA1/2 genetic counseling as to when and how information about PGD/PND should be presented (e.g., timing, level of detail,etc)
大体时间：conclusion of study
|
conclusion of study
|
|
To explore whether different themes emerge for subgroups of patients (completed childbearing vs. not; affected vs. unaffected).
大体时间：conclusion of study
|
conclusion of study
|
|
To gain preliminary data on themes that might be particularly important to male BRCA1/2 carriers.
大体时间：conclusion of study
|
conclusion of study
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Karen Hurley, PhD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年3月1日
初级完成 (实际的)
2010年10月1日
研究完成 (实际的)
2010年10月1日
研究注册日期
首次提交
2008年8月12日
首先提交符合 QC 标准的
2008年8月12日
首次发布 (估计)
2008年8月14日
研究记录更新
最后更新发布 (估计)
2010年10月11日
上次提交的符合 QC 标准的更新
2010年10月8日
最后验证
2010年10月1日
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.