Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of Abnormalities Detected by EUS
研究概览
简要总结
The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the development of pancreatic cancer. Endoscopic refers to the use of an instrument called an endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound refers to an imaging technique that uses sound waves to produce pictures. EUS in this research study is a method of combining endoscopy and ultrasound imaging to obtain high quality images of the pancreas.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will be eligible if they have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least one of the relatives with pancreatic cancer
- •If only 2 family members are affected then both must have had pancreatic cancer and a first-degree relationship with individual screened
- •If there are more than 2 affected individuals on the same side of the family at least one of the individuals must have a first-degree relationship with the member being screened
- •Patients at least 40 years old or 10 years younger than the youngest affected individual
- •Peutz-Jeghers Syndrome (PJS) patients age>30
- •Hereditary pancreatitis patients
- •Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)
- •Patients with BRCA2 mutation and at least one first or second degree relative with documented pancreatic cancer
- •Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)
- •Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
- •Willingness to undergo radiographic evaluation if screening findings are abnormal
排除标准
- •Medical contraindications to undergoing endoscopy or obstruction of the GI tract that precludes passage of the endoscope
- •Personal history of pancreatic adenocarcinoma
- •Previous partial or complete resection of the pancreas for adenocarcinoma
- •Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis
- •Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years
- •Coexisting cancer in other organs or acquired immunodeficiency syndrome/human immunodeficiency virus (AIDS/HIV)
- •Life expectancy less than 5 years
- •Pregnancy
结局指标
主要结局
Number of Abnormalities Detected by EUS
时间窗: Average of 5 years
To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.
次要结局
未报告次要终点