NCT03082976已完成不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Prevalence of somatic BRCA mutations among ovarian cancer patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Prevalence of somatic BRCA mutations among ovarian cancer patients
时间窗: Up to 4 Weeks for BRCA testing result
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
次要结局
- Describe epidemiological characteristics(Up to 4 Weeks for BRCA testing result)
- Describe treatment modalities(Up to 4 Weeks for BRCA testing result)
- Associations or correspondence in prevalence between genetic alterations(Up to 4 Weeks for BRCA testing result)
- Categorize epideimiological charactersitics and clinical features(Up to 4 Weeks for BRCA testing result)
研究者
研究点 (1)
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