Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region (PREDICT)
2020年7月15日 更新者:AstraZeneca
PREDICT: Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region. A Prospective, Multi-centre, Epidemiological Observational Study Designed to Evaluate the Prevalence of BRCA1 and BRCA2 Mutations in Current and Newly Diagnosed Ovarian Cancer Patients Across Different Countries in the Gulf Region. This Study Study Will Also Describe the Epidemiological Features for the Disease for the Enrolled Patients.
A prospective, multi-centre, epidemiological observational study designed to evaluate the prevalence of BRCA1 and BRCA2 (BReast CAncer gene) mutations in current and newly diagnosed ovarian cancer patients across different countries in the Gulf region.
This study will also describe the epidemiological features for the disease for the enrolled patients.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
108
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
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Al Ain、阿拉伯联合酋长国
- Research Site
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
The target study population will be women at least 18 years of age with histologically confirmed ovarian, peritoneal, and fallopian tube cancers at participating oncology hospitals/departments in the Gulf region.
Patients enrolled in this study will be assigned to either the treatment-experienced subgroup for those who were previously diagnosis and are undergoing treatment at the time of enrollment, or the treatment-native group for those who were recently diagnosed and not yet undergoing treatment.
描述
Inclusion Criteria:
- Subjects willing to sign the informed consent form (ICF)
- Female subjects 18 years of age or older
Have histologically confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) ovarian epithelial, primary peritoneal cancer made by one or more of the following:
- Standard staging laparotomy including bilateral salpingo-oophorectomy,omentectomy, and lymph node sampling and debulking and/or
- Surgical resection and radiographic evidence consistent with ovarian cancer
- Paracentesis or biopsy with radiographic evidence consistent with ovarian cancer(normal appearing pancreas, liver, and gastrointestinal tract).
- Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if a block is not possible, a minimum of twenty 10-um sections.
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible to participate in the study and hence will not be consented:
- The diagnosis is not of a primary ovarian cancer; thus, patients will be excluded if a previous cancer has metastasized to the ovary, or if there is a secondary malignancy that is associated with the ovarian cancer.
- Is not able or willing to provide written informed consent.
- Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study.
- Be a patient who, in the judgment of the Investigator, would be inappropriate for enrollment in this study.
A rationale will be documented for all patients who are screened and ultimately excluded from the study as a result of meeting any of the aforementioned exclusion criteria
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
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Prevalence of somatic BRCA mutations among ovarian cancer patients
大体时间:Up to 4 Weeks for BRCA testing result
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The primary objective of this study is to discern the prevalence of somatic BRCA1 and BRCA2 mutations in patients with ovarian cancer, peritoneal cancer, and fallopian tube cancer, as assessed by tissue genetic testing in tumor samples
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Up to 4 Weeks for BRCA testing result
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Associations or correspondence in prevalence between genetic alterations
大体时间:Up to 4 Weeks for BRCA testing result
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Examine associations (or correspondence) in prevalence between genetic alterations in hereditary (germline) and tissue (somatic) BRCA mutations by testing for germline (blood) mutations in those patients who are known to have somatic mutations
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Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics
大体时间:Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics (e.g., age, ethnicities) of patients being treated for ovarian cancer.
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Up to 4 Weeks for BRCA testing result
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Describe treatment modalities
大体时间:Up to 4 Weeks for BRCA testing result
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Describe treatment strategy among the treatment-experienced subgroup of patients who were previously diagnosed with ovarian cancer
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Up to 4 Weeks for BRCA testing result
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Categorize epideimiological charactersitics and clinical features
大体时间:Up to 4 Weeks for BRCA testing result
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Describe epidemiological characteristics(e.g.
Comorbidities, stage) of patients being treated for ovarian cancer
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Up to 4 Weeks for BRCA testing result
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Compare standards of care practices
大体时间:Up to 4 Weeks for BRCA testing result
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An exploratory objective is to compare standards of care and pre- and post-diagnosis practices in each country, for example, with respect to tissue collection, processing, storage and maintenance, which is of great importance to future studies building on the present study.
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Up to 4 Weeks for BRCA testing result
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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。
赞助
调查人员
- 首席研究员:Mohammed Jaloudi, MD、Tawam Hospital
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。
有用的网址
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 (实际的)
2017年7月16日
初级完成 (实际的)
2019年7月24日
研究完成 (实际的)
2019年7月24日
研究注册日期
首次提交
2017年2月27日
首先提交符合 QC 标准的
2017年3月13日
首次发布 (实际的)
2017年3月17日
研究记录更新
最后更新发布 (实际的)
2020年7月16日
上次提交的符合 QC 标准的更新
2020年7月15日
最后验证
2020年7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.