Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change of mesenchymal stem cell (MSC)-derived cancer support factors
研究概览
简要总结
This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.
详细描述
PRIMARY OBJECTIVE:
I. To determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.
OUTLINE:
Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with ovarian cancer starting PARP inhibitor treatment
排除标准
- •Patients unwilling to return for blood draws, patients unwilling to continue PARP inhibitor treatment for at least one month
结局指标
主要结局
Change of mesenchymal stem cell (MSC)-derived cancer support factors
时间窗: At four weeks post PARP inhibitor treatment
Levels of MSC-derived cancer support factors will be compared to baseline (i.e. pre-PARPi therapy) at each collection time point by Student's t test. In addition, outcomes by Cox proportional hazards will be compared between designated responders (i.e. patients whose MSC-derived cancer support factors decreased after PARP inhibition) and non-responders (i.e. patients whose MSC-derived cancer support factors did not decrease after PARP inhibition)
次要结局
- Progression-free survival(Up to 2 years)