Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 631
- 试验地点
- 1
- 主要终点
- This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.
研究概览
简要总结
CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer.
详细描述
Pancreatic cancer is a deadly disease and the only hope for improvement of survival is early detection. Certain genetic syndromes are associated with a high risk of pancreatic cancer and screening for pancreatic cancer has become a relatively new strategy for familial pancreatic cancer. . Our pancreatic cancer research group at Johns Hopkins and others have shown that screening with EUS and/or abdominal imaging tests such as CT/MRI can detect a relatively high number of significant pancreatic neoplasms (7-18%) in asymptomatic high risk individuals with an inherited predisposition for pancreatic ductal adenocarcinoma This is a clinical, early detection translational study that will directly influence patient care. This long term study follows the successful completion of single center Cancer of the Pancreas (CAPS) 1 and CAPS 2 studies at Johns Hopkins, and the ongoing CAPS 3 multicenter study. GENERAL AIM: This is a study that aims to evaluate the diagnostic yield, quality of life, and clinical outcomes of a clinical screening and surveillance program for individuals at-risk for pancreatic cancer and to validate a candidate panel of biomarkers for early detection of pancreatic neoplasia. The 3 specific groups to be screened and followed are individuals from familial pancreatic cancer kindreds (who have 2 or more affected relatives and have an estimated risk 16-57 times that of controls), patients with familial Peutz-Jeghers syndrome, patients with a known BRCA-2, BRCA-1, PALB2, PRSS or p16 germline mutation.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High Risk Group 1 (familial Peutz-Jeghers syndrome):
- •At least 30 years old and <100 years old, and
- •at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome)
- •known STK-11 gene mutation carrier
- •High Risk Group 2 (familial pancreatic cancer relatives):
- •> 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old
- •come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and
- •have a first-degree relationship with at least one of the relatives with pancreatic cancer.
- •If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened
- •High Risk Group 3 (germline mutation carriers):
- •> 40 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old
- •patient is carrier of a known BRCA1, BRCA2, PALB2, or FAMMM (p16/CDKN2A) mutation, and there is > 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.
- •Hereditary pancreatitis syndrome
- •High Risk Group 4 (young-onset pancreatic cancer relative):
- •> 50 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and < 80 years old
- •have a first-degree relationship with at least one relative with young-onset pancreatic cancer ( age of onset < 50 years)
- •High risk group 5 (both parents affected)
- •> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and< 80 years old
- •two parents affected by pancreatic cancer
- •Control 1 (Negative Controls):
- •are undergoing EUS and/or ERCP for non-pancreatic indications as part of their standard medical care, and
- •have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)
- •Control 2 (Chronic Pancreatitis)
- •are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and,
- •have no clinical or radiologic suspicion of pancreatic cancer
- •Control 3 (Pancreatic Cancer)
- •a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)
- •Control 4 (Intraductal Papillary Mucinous Neoplasm or IPMN) a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and/or pancreatic cystic lesion communicating with the pancreatic ductal system)
- •Additional requirements for eligible high risk patients: i) All persons with known genetic mutation must have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt should be made to confirm pancreatic cancers in the family members via registration in a pancreatic cancer registry iii) The affected first degree relative of the person being screened must be confirmed by medical record or death certificate.
- •All control patients must be > 18 and < 80 years old and no personal or family history of pancreatic cancer or a germline mutation linked to pancreatic cancer.
排除标准
- •Patients will be excluded if they have any of the following:
- •medical comorbidities or coagulopathy that contraindicate endoscopy,
- •Karnosfky performance status of < 60,
- •had partial or complete resection of their pancreas
- •had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis
- •a stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
- •life expectancy less than 5 years due to coexisting advanced cancer or AIDS.
- •inability to provide informed consent
- •pregnant patient
- •history of pancreatic cancer,
- •suspicion of pancreatic neoplasia based on clinical history (weight loss, unexplained abdominal pain), physical examination (obstructive jaundice, cachexia), laboratory tests (cholestastic liver function tests, markedly elevated CA19-9), and/or imaging studies (pancreatic mass or cyst, dilated pancreatic and/or bile duct);
- •there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by screening.
- •history of chronic kidney disease, serum creatinine > 2.0 mg/dl or estimated glomerulofiltration rate (eGFR) < 30 ml/min, ongoing acute renal failure, cirrhosis of the liver, chronic hepatitis (The estimated glomerulfiltration rate (eGFR) will be calculated based on age, race, and serum creatinine, using the on-line calculator at nephron.com).
- •history of dementia
结局指标
主要结局
This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.
时间窗: 5 years
次要结局
未报告次要终点