Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
研究概览
简要总结
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.
详细描述
Interested individuals can be referred by physicians, or by family or friends.
Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.
Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.
We have a weekly review of all calls made and of all enrollments.
We have a monthly meeting to review all proceeding regarding the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Any of the following:
- •Known carrier of either the BRCA2 or CDKN2A mutation;
- •Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;
- •Individual with Peutz-Jeghers Syndrome;
- •Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;
- •Both parents affected, any age:
- •Any first degree relative diagnosed with pancreatic cancer under age 50;
- •Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history
排除标准
- •Any medical condition that contraindicates endoscopy or biopsy
- •Any medical condition that contraindicates MRI
- •Status post partial or complete resection of the pancreas
- •History of pancreatic cancer, either endocrine or exocrine
- •Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).
- •diagnosis of dementia
- •Uncontrolled, current illness
- •Renal insufficiency with serum creatinine greater than 2.0 mg/dl
研究组 & 干预措施
Individuals at elevated risk for pancreatic cancer
Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.
干预措施: Endoscopic Ultrasound (Procedure)
Individuals at elevated risk for pancreatic cancer
Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
时间窗: 5 years
Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
次要结局
- Non-Pancreatic cancers diagnosed while on this protocol(5 years)
- Clinical outcomes which occur as a result of this Protocol(5 years)
- Complications of any interventions as a result of this Protocol(5 years)
研究者
Joshua Raff, MD
Director, Digestive Cancer Program, Center for Cancer Care
White Plains Hospital