A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Measure the endothelial reactivity (PAT-RH) in both groups
研究概览
简要总结
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cisplatin-Based Chemotherapy Group
- •Histologically-proven diagnosis of GCT
- •No prior exposure to chemotherapy or radiation
- •Planned to receive 3-4 cycles of cisplatin-based chemotherapy
- •Surgery-Only Group
- •Histologically-proven diagnosis of GCT Male
- •Surgical management of GCT performed less than 90 days before start of study (includes orchiectomy and primary retroperitoneal lymph node dissection (RPLND))
- •No prior exposure to chemotherapy or radiation
排除标准
- •Cisplatin-Based Chemotherapy Group
- •Prior exposure to chemotherapy or radiation
- •Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease
- •Surgery-Only Group
- •Prior exposure to chemotherapy or radiation
- •Planned for non-surgical management with chemotherapy or radiation.
- •Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease.
结局指标
主要结局
Measure the endothelial reactivity (PAT-RH) in both groups
时间窗: 15 minutes
The Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard BP cuff).
次要结局
- Identify sociodemographic(2 years)
- Identify comorbid health conditions(2 years)
- Measure PAT-RH index(2 years)