Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Endpoint OP1
研究概览
简要总结
This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1/2 and HRD status.
详细描述
The overall objective of the study is to demonstrate the distribution of ovarian cancer by HRD and BRCA1/2 mutational status and further characterize sub-cohorts of long- and short-term responders. Additionally, to collect representative clinical samples for further translational analyses.
The overall objective is separated by two distinct observational periods defined as Observational Period 1 (OP1) and Observational Period 2 (OP2):
- OP1: From date of diagnosis to date of first response assessment following 1L chemotherapy, progression or death, whichever occurs first
- OP2: From date of first response assessment following 1L chemotherapy to maximum 36 months following 1L chemotherapy, death or withdrawal of consent, whichever occurs first.
Objective for Observational Period 1 (OP1) The objective for OP1 is to demonstrate the distribution of ovarian cancer patients with FIGO stage I-II BRCA1/2mut ovarian cancer, or stage III-IV ovarian cancer in cohorts of BRCA1/2, HRD (either BRCA1/2 mutation and/or genomic instability), HRP and HR-unknown patients.
Objective for Observational Period 2 (OP2) The objective for OP2 is to further characterize sub-cohorts of short-term responders (progressing < 6 months following maintenance treatment) and long-term responders (progressing ≥ 32 months following maintenance treatment) in real-world cohorts of ovarian cancer patients. For FIGO stage I-II BRCA1/2mut or FIGO stage III-IV defined by HRD status determined by Myriad myChoice® CDx HRD test or non-Myriad local HRD test, and BRCA1/2 status.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Endpoint OP1
时间窗: 36 months
Frequency of surgical resection
次要结局
- Endpoints OP1 - 1.2(36 months)
- Endpoints OP1 - 1.3(36 months)
- Endpoints OP1 - 1.4(36 months)
- Endpoint OP2 - 2.2(36 months)
- Endpoints OP1 - 1.1(36 months)
- Endpoint OP2 - 2.1(36 months)
