China Ovarian Cancer BRCA Testing Study (CRONUS)
China Local BRCA Testing and Exploration of Ovarian Cancer Treatment Outcomes of Different BRCA Status in Newly Diagnosed Epithelial Ovarian Cancer Patients
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Anhui
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Hefei、Anhui、中国、230601
- Research Site
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Beijing
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Beijing、Beijing、中国、100142
- Research Site
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Beijing、Beijing、中国、100191
- Research Site
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Beijing、Beijing、中国、100730
- Research Site
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Chongqing
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Chongqing、Chongqing、中国、400030
- Research Site
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Guangdong
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Guangzhou、Guangdong、中国、510060
- Research Site
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Guangzhou、Guangdong、中国、510080
- Research Site
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Guangzhou、Guangdong、中国、510220
- Research Site
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Henan
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Zhengzhou、Henan、中国、450008
- Research Site
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Hubei
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Wuhan、Hubei、中国、430030
- Research Site
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Hunan
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Changsha、Hunan、中国、410000
- Research Site
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Shandong
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Jinan、Shandong、中国、250014
- Research Site
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Shanghai
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Shanghai、Shanghai、中国、200032
- Research Site
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Shanghai、Shanghai、中国、200080
- Research Site
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Sichuan
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Chengdu、Sichuan、中国、610041
- Research Site
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Tianjin
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Tianjin、Tianjin、中国、300110
- Research Site
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Tianjin、Tianjin、中国、300202
- Research Site
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Zhejiang
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Hangzhou、Zhejiang、中国、310006
- Research Site
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Hong Kong、香港
- Research Site
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Be able and willing to sign the informed consent form (ICF)
- Female aged 18 years or over
Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made by one or more of the following:
- standard staging laparotomy including bilateral salpingo-oophorectomy, omentectomy, and lymph node sampling and debulkingand/or
- surgical resection and radiographic evidence consistent with Stage III or IV ovarian cancer
- biopsy with radiographic evidence consistent with Stage III or IV ovarian cancer
- Have availability of paraffin-embedded archivedtumor tissue block (preferred) or,if a block is not possible, a minimum of twenty 5-μm unstained sections. (Tumor tissue should be archived at diagnosis. 10 slides is utilized for sBRCA testing after the enrolment. Another 10 slides is utilized for exploratory evaluation of HRR gene mutations in a retrospective way.)
- Have a diagnosis that is within 60 days of informed consent
Exclusion Criteria:
- Have a diagnosis of additional concurrent malignancies or previous diagnosis of another malignancy with current evidence of residual disease
- 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 results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study
- Be currently participating in any other clinical trial for first-line treatment of ovarian cancer
- Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study
学习计划
研究是如何设计的?
设计细节
- 观测模型:案例交叉
- 时间观点:预期
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 |
---|---|---|
Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
大体时间:1 year
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To evaluate the prevalence of gBRCA mutation and sBRCA mutation in newly diagnosed ovarian cancer patients
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1 year
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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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Progression-free survival (PFS)
大体时间:18 months
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To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of PFS
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18 months
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Overall survival (OS)
大体时间:up to 5 years
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To describe ovarian cancer treatment outcomes in patients during the Follow up Period in terms of OS
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up to 5 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of newly diagnosed ovarian cancer patients with HRR gene mutations
大体时间:1 year
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To evaluate the prevalence of homologous recombination repair (HRR) gene mutations in newly diagnosed ovarian cancer patients
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1 year
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合作者和调查者
赞助
调查人员
- 学习椅:Jinghe Lang, Dr、Peking Union Medical College Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- D133FR00117
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享时间框架
AstraZeneca has a long-standing commitment to making information about our clinical research publicly available. We believe that transparency enhances the scientific understanding of how our medicines work and is in the medical interest of our patients.
We publish information on the registration and results of all new and ongoing AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued. We post results, irrespective of whether they are favourable or unfavourable to AstraZeneca.
IPD 共享访问标准
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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