Biomarker Discovery Project in High Grade Serous Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 13
- 主要终点
- Genomic and immune signatures in terms of progression free survival
研究概览
简要总结
This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer.
- •Must be 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Have a life expectancy greater than or equal to 6 months.
- •Able to provide adequate informed consent.
- •Willing to undergo blood or fluid collection and tumour biopsy
- •Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study.
- •Archival tissue must be available for patients that are enrolled at the time of progression.
排除标准
- •Must not have early stage (I and II) high grade serous, tubal or primary peritoneal cancer.
- •Must not have other tumour histology other than high grade serous.
- •Must not have contraindication to tumour biopsy and/or blood sampling.
结局指标
主要结局
Genomic and immune signatures in terms of progression free survival
时间窗: 10 years
Short term (1-2 years) versus long term (5-10 years) survival
Genomic and immune signatures in terms of overall survival
时间窗: 10 years
Short term (1-2 years) versus long term (5-10 years) survival
Genomic and immune signatures in terms of response to treatments
时间窗: 10 years
Genomic and immune signatures in terms of resistance to treatments
时间窗: 10 years
次要结局
未报告次要终点