The Cancer of the Pancreas Screening-5 CAPS5)Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 9,000
- 试验地点
- 9
- 主要终点
- Evaluate pancreatic juice for early cancer markers.
研究概览
简要总结
Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
详细描述
The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking of the diagnostic test results
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
- •Hereditary Pancreatitis or
- •Peutz-Jeghers Syndrome or
- •Strong family history of pancreas cancer on one side of the family tree or
- •Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
- •Endoscopic evaluation of pancreas scheduled
排除标准
- •Medical comorbidities or coagulopathy that contraindicate endoscopy
- •Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
- •Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
- •Poor performance status
- •Inability to provide informed consent
- •Pregnancy.
研究组 & 干预措施
Familial pancreas cancer relatives
High Risk Group 2 (familial pancreatic cancer relatives):
- > 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and
- 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
干预措施: Secretin (Drug)
Familial pancreas cancer relatives
High Risk Group 2 (familial pancreatic cancer relatives):
- > 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and
- 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
干预措施: MRI (Diagnostic Test)
Familial pancreas cancer relatives
High Risk Group 2 (familial pancreatic cancer relatives):
- > 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and
- 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
干预措施: Tumor marker gene test with CA19-9 (Other)
Group 1 germline mutation carrier
High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher):
a. > 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.
干预措施: Secretin (Drug)
Group 1 germline mutation carrier
High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher):
a. > 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.
干预措施: MRI (Diagnostic Test)
Group 1 germline mutation carrier
High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~10% or higher):
a. > 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.> Individual is a carrier of a confirmed FAMMM (p16/CDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.
干预措施: Tumor marker gene test with CA19-9 (Other)
Group 2 germline mutation carrier
High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
- > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and
- The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene 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.
干预措施: Secretin (Drug)
Group 2 germline mutation carrier
High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
- > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and
- The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene 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.
干预措施: MRI (Diagnostic Test)
Group 2 germline mutation carrier
High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of ~5%):
- > 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and
- The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene 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.
干预措施: Tumor marker gene test with CA19-9 (Other)
Hereditary pancreatitis
High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.
干预措施: Secretin (Drug)
Hereditary pancreatitis
High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.
干预措施: MRI (Diagnostic Test)
Pancreas 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)
干预措施: Secretin (Drug)
Hereditary pancreatitis
High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.
干预措施: Tumor marker gene test with CA19-9 (Other)
Peutz-Jeghers Syndrome
- At least 30 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), or,
- known STK11 gene mutation carrier
干预措施: Secretin (Drug)
Peutz-Jeghers Syndrome
- At least 30 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), or,
- known STK11 gene mutation carrier
干预措施: MRI (Diagnostic Test)
Peutz-Jeghers Syndrome
- At least 30 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), or,
- known STK11 gene mutation carrier
干预措施: Tumor marker gene test with CA19-9 (Other)
Negative control
- are undergoing routine EGD or Colonoscopy; or Endoscopic Ultrasound (EUS) and/or Endoscopic Retrograde Cholangiopancreatography (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)
干预措施: Secretin (Drug)
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
干预措施: Secretin (Drug)
Pancreas cyst, IPMN evaluation
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).
干预措施: Secretin (Drug)
结局指标
主要结局
Evaluate pancreatic juice for early cancer markers.
时间窗: 10 years
Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.
次要结局
- Compare pancreas juice with pancreas cyst fluid(10 years)