Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
研究概览
简要总结
This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Case groups (matching any of the following):
- •Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
- •Patients who are the high-risk group of pancreatic cancer.
- •Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
- •Patients with other diseases with abnormally elevated CA19-
- •Control group:
- •(1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
排除标准
- •Patients who are younger than 18 years of age.
- •Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
- •Patients who have not signed informed consent.
结局指标
主要结局
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
时间窗: 2 years
The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
次要结局
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)(2 years)
- The content of elastase 1(2 years)