A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
研究概览
简要总结
This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.
详细描述
PRIMARY OBJECTIVE:
I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC).
SECONDARY OBJECTIVES:
I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies.
II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand and be willing to sign a written informed consent document
- •Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy
排除标准
- 未提供
研究组 & 干预措施
Observational (medical records review)
Patients' medical records are reviewed.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
时间窗: Up to 5 years
For each toxicity, will estimate the odds ratio, associated 95% confidence interval and p-value.
次要结局
未报告次要终点