NCT04883450进行中（未招募）不适用
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group
研究概览
简要总结
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.
详细描述
The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.
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
- 50 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have 6 months of membership
- •Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
- •Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
- •Speaks English or Spanish
排除标准
- •Previous or current history of pancreatic cancer
- •Metastatic cancer
- •Current active cancer or undergoing chemotherapy for cancer
- •Currently pregnant or breastfeeding
- •Class IV heart failure
- •Cirrhosis with ascites and/or varices
- •Currently in a skilled nursing facility or under hospice care
- •Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
- •End stage renal disease
- •Cognitive impairment such that the person is unable to provide informed consent
结局指标
主要结局
Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group
时间窗: 18-Month
Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC
次要结局
未报告次要终点
研究者
研究点 (1)
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