Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 263
- 试验地点
- 3
- 主要终点
- Identification of Biomarkers for Early Pancreatic Cancer Detection
研究概览
简要总结
Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.
详细描述
Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, and only 10-15% of all pancreatic cancer patients are operable or borderline operable.
Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood.
Duodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer.
However, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or
- •Be at least 19 years old.
- •Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- •A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).
- •Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy.
- •The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or
- •Be at least 19 years old.
- •Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- •Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
- •No evidence of a pancreatic disease.
排除标准
- •The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
- •Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.
- •Hemodynamically unstable and unable to have an endoscopy performed.
- •A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.
- •A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.
结局指标
主要结局
Identification of Biomarkers for Early Pancreatic Cancer Detection
时间窗: Up to 1 year from baseline
Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.
次要结局
- External Validation Using U.S. Samples(Up to 2 year from baseline)
研究者
Do Hyun Park
Professor
Asan Medical Center