| Registry | NCT02000089, acronym CAPS5 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; non randomized, single group, masking: none, diagnostic |
| Enrollment | 9000 (Estimated) |
| Sponsor | Johns Hopkins University (Other); collaborators: National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research |
| Conditions | Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier, Lynch Syndrome |
| Interventions | Secretin, MRI, Tumor marker gene test with CA19-9 (Drug, diagnostic test, other) |
| Dates | start 2014-01-06, primary completion 2028-12-01 (estimated), completion 2029-06-01 (estimated), first posted 2013-12-03, last updated 2026-10-22 |
| Locations | 9 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Pancreas Cancer All trials for Peutz-Jeghers Syndrome (PJS) All trials of Secretin All trials of MRI
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Familial pancreas cancer relatives | Active comparator | Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 | 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 |
| Group 1 germline mutation carrier | Active comparator | Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 | 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. |
| Group 2 germline mutation carrier | Active comparator | Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 | 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. |
| Hereditary pancreatitis | Active comparator | Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 | 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. |
| Peutz-Jeghers Syndrome | Active comparator | Drug: Secretin; Diagnostic Test: MRI; Other: Tumor marker gene test with CA19-9 | 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 |
| Negative control | Active comparator | Drug: Secretin | 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) |
| Chronic Pancreatitis | Active comparator | Drug: Secretin | 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 |
| Pancreas cancer | Active comparator | Drug: Secretin | 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) |
| Pancreas cyst, IPMN evaluation | Active comparator | Drug: Secretin | 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). |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Yale University | New Haven, Connecticut | United States | Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland | United States | Recruiting |
| Dana Farber Cancer Center, Harvard University | Boston, Massachusetts | United States | Recruiting |
| University of Michigan | Ann Arbor, Michigan | United States | Recruiting |
| NYU Langone Medical Center | New York, New York | United States | Recruiting |
| Columbia University Medical Center | New York, New York | United States | Recruiting |
| Case Comprehensive Cancer Center, Case Western Medical Reserve | Cleveland, Ohio | United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania | United States | Recruiting |
| University of Pittsburgh | Pittsburgh, Pennsylvania | United States | Recruiting |
NIH grants: U01CA210170, R01CA176828