ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Survival
研究概览
简要总结
This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.
详细描述
The purpose of the registry is to collect data on the performance of the focused ultrasound (FUS) technology and health outcomes. A wide variety of approaches exist for using FUS on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. This information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions.
Enrollment Goal: 100
Primary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all registry procedures and availability for the duration of the registry
- •Histology proven pancreatic carcinoma in any area of pancreas
- •Pancreatic tumor that can be treated by FUS
- •Willingness and ability to complete follow-up interviews
排除标准
- •Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
- •Clinical trials of pancreatic cancer not of focused ultrasound or related activities
- •Other non-pancreatic cancer clinical trials
结局指标
主要结局
Survival
时间窗: 1 year
Time until the occurence of death
次要结局
未报告次要终点