An observational study exploring the association of the completeness of cytoreductive surgery and surgical complexity score with the BRCA mutation status in patients with high grade serous ovarian cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Primary outcome- To determine the association of germline BRCA mutations with rates of complete cytoreduction
研究概览
简要总结
Background: Ovarian cancer is the leading cause of death among women with all gynecological cancers. Around 15-20% of high-grade serous ovarian carcinomas (HGSOC) are associated with BRCA mutation. BRCA-associated HGSOC have better overall survival (OS). It is already established that they respond better to platinum-based chemotherapy. The primary treatment in ovarian cancer is surgery and residual tumour after surgery is an independent prognostic factor for OS. Unique histology of BRCA mutated HGSOC might allow for complete resectability of tumor. Our study aims to find the association between germline BRCA mutation and complete cytoreduction at surgery.
Aim:This study aims to investigate whether BRCA mutation is an independent predictor for complete cytoreduction in HGSOC.
Materials and methods: The patients of HGSOC evaluated and operated in TMCK and having been tested for germline mutation from the Institution will be included in this study. The patients will be compared depending on the presence or absence of BRCA germline mutations. The prospective study will be for twenty-three months from March 2024 to October 2025, including data collection and data analysis with a minimum of 3 months follow up. To complete the sample size of 287 patients, surgical data will be collected from 01/01/23 onwards. The data on demographic details, germline mutations, intraoperative details regarding complete cytoreduction (CC) scores, surgical complexity scores (SCS), intraoperative and postoperative complications will be collected from prospectively maintained retrospective records in the hospital electronic medical records. The follow-up data will be collected prospectively following departmental protocol for OS and PFS. Descriptive statistics will be elaborated in the form of means and standard deviations and medians and IQRs for continuous variables, and frequencies and percentages for categorical variables. The association of BRCA mutation with completeness of cytoreduction will be assessed by linear correlation using Pearson’s correlation or Spearman’s correlation
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •High grade serous ovarian cancer (HGSOC) patients who had primary surgery which includes primary debulking surgery, interval debulking surgery and completion surgery at Tata Medical Center Kolkata
- •More than 18 years of age.
排除标准
- •Epithelial ovarian cancers other than HGSOC and non-epithelial ovarian cancer patients.
- •Repeat cytoreductive surgery after disease recurrence.
- •Less than 18 years.
结局指标
主要结局
Primary outcome- To determine the association of germline BRCA mutations with rates of complete cytoreduction
时间窗: Final analysis of association between complete cytoreduction and BRCA mutation status will be done after complete recruitement of sample size that is in December 2025
次要结局
- To determine the association of germline BRCA mutation with surgical complexity score.(To estimate the progression free survival (PFS) & overall survival (OS) in the above cohort of patients)
研究者
Basumita Chakraborti
Tata Medical Center, Kolkata