An ambispective crosssectional multi-center non interventional cohort study to evaluate the clinical profile of ovarian cancer patients initiated on Olaparib and correlation of mutation status (BRCA & HRD) with clinicopathologic characteristics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cipla Ltd
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Baseline demography including molecular characteristics age gender comorbidities primary treatment family history BRCA1 BRCA2 mutation and HRD status
研究概览
简要总结
Ovarian cancer is a leading cause of cancer-related mortality among women. Olaparib, a PARP inhibitor, is indicated in the treatment of Ovarian cancer patients with specific genetic mutations – BRCA & HRD. Comprehensive data from multiple centers across India on the real-world usage of Olaparib in eligible ovarian cancer patients, remains limited for a larger subset of patients. Additionally, demographic and clinicopathological data on ovarian cancer patients receiving Olaparib is not widely available in India, necessitating this study to bridge the data gap. By addressing these deficiencies, this study aims to evaluate the clinical profiles of OC patients prescribed with Olaparib, focusing on their baseline demographics including molecular characteristics, response to previous treatments, and to assess correlation of BRCA/HRD with clinicopathologic characteristics.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patient of more than or equal to 18 years of age Previously treated or newly diagnosed ovarian primary peritoneal or fallopian tube cancer patients prescribed on Olaparib naïve or initiated equal to or less than 3 months Mutation status BRCA positive or HRD plus BRCA negative or HRD positive.
排除标准
- •Failed to provide written informed consent Any medical condition that in the opinion of the investigator would interfere with safe completion of the study, or were participating in any other clinical.
结局指标
主要结局
Baseline demography including molecular characteristics age gender comorbidities primary treatment family history BRCA1 BRCA2 mutation and HRD status
时间窗: Baseline
次要结局
- Assess the co-relation of BRCA and HRD status(Lifestyle medical history and symptoms)
研究者
Dr Narayanan Kutty Warrier
MVR Cancer Center and Research Institute