The Cancer of the Pancreas Screening-5 CAPS5)Study
Who is this study for? Patients with hereditary pancreatitis or
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other, Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Massachusetts
Dana Farber Cancer Center, Harvard University
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
New York
Columbia University Medical Center
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
Ohio
Case Comprehensive Cancer Center, Case Western Medical Reserve
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Hilary Cosby, RN
hcosby1@jhmi.edu
Time Frame
Start Date: 2014-01-06
Estimated Completion Date: 2029-06
Participants
Target number of participants: 9000
Treatments
Active_comparator: Familial pancreas cancer relatives
High Risk Group 2 (familial pancreatic cancer relatives):~1. \> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and~2. 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~3. 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
Active_comparator: 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.
Active_comparator: 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%):~1. \> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and~2. 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.
Active_comparator: 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.
Active_comparator: Peutz-Jeghers Syndrome
1. At least 30 years old, and~2. 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,~3. known STK11 gene mutation carrier
Active_comparator: Negative control
1. 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~2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)
Active_comparator: Chronic Pancreatitis
1. 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,~2. have no clinical or radiologic suspicion of pancreatic cancer
Active_comparator: 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)
Active_comparator: 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).
Authors
Randy Brand, Anil Rustgi, Andrew Rhim
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), American Association for Cancer Research
Leads: Johns Hopkins University