CTRI/2018/08/015338已完成不适用
A Non-interventional, multicentre study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India ( BRCA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The proportion of previously and newly diagnosed ovarian, primary peritoneal or fallopian tube cancer patients with BRCA1 or BRCA2 mutations positive status.
研究概览
简要总结
This is a non-interventional, cross-sectional, multicentre, prospective, observational study to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 240 patients with nearly 16 patients per site over 6 months. The study will enrol females with diagnosis of ovarian, primary peritoneal, or fallopian tube cancer. No study medication will be prescribed or administered as a part of study procedure.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients who provide written informed consent
- •Female ≥ 18 years of age
- •Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients.
排除标准
- •Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
- •Patient participating in any other clinical study/ trial.
结局指标
主要结局
The proportion of previously and newly diagnosed ovarian, primary peritoneal or fallopian tube cancer patients with BRCA1 or BRCA2 mutations positive status.
时间窗: One day
次要结局
- 1. Level of association between histopathological type and BRCA 1/BRCA 2 mutation positive status(One day)
- 2. To assess the association of BRCA1/BRCA2 mutation positive status and family history of breast and/or ovarian cancer and any cancer.(• Patients having Family history of Ovarian cancer in first degree relative)
- 3. To determine the BRCA1/BRCA2 mutation distribution in Indian population.(NA)
研究者
研究点 (1)
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