Prospective Cohort Study for Validation of Predictive Immune Biomarkers of Response to PAPR Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Validation of biomarkers for predicting response to PAPR inhibitor
研究概览
简要总结
Increasing number of ovarian cancer patients are receiving PARP inhibitor as maintenance therapy. Predictive factors to PARP inhibitor other than BRCA mutation or HRD status are unknown. Previous study, we analyzed the dynamic immunological changes in peripheral T cells during PARP inhibitor maintenance therapy and found predictive biomarkers. The purpose of this study is to prospectively validate the biomarkers for predicting response to PAPR inhibitors in ovarian cancer. We collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive PARP inhibitor and analyze immunological characteristics of peripheral CD8 and regulatory T cells. Through assessment of the baseline properties and dynamic changes in T cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of epithelial ovarian cancer,
- •Presence of germline or somatic BRCA mutational status result,
- •Advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start PARPi (olaparib or niraparib) maintenance therapy.
排除标准
- •Patients who refuse to participate,
- •Patients having difficulty understanding the protocol due to language barrier
结局指标
主要结局
Validation of biomarkers for predicting response to PAPR inhibitor
时间窗: The primary endpont will be accessed 12 months after last patient registration.
Investigators will utilize baseline peripherap blood mononuclear cells (PBMCs) to validate predictive biomarkers to PARP inhibitor. Response to PAPR inhibitor was defined by BRCA1/2 status and duration of PAPR inhibitor treatment.
次要结局
- Identify promising novel targets to enhance survivla outcomes of high-risk pateints in PAPR inhibitor therapy.(Identify promising novel targets (Time Frame: 12 months))
- Identify dynamic immunological changes during PAPR inhibitor therapy(Immunological changes (Time Frame: 6 months)