- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2014-01-06
2025-10
2025-12
9000
NCT02000089
Johns Hopkins University
Johns Hopkins University
INTERVENTIONAL
The Cancer of the Pancreas Screening-5 CAPS5)Study
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-11-26 | N/A | 2025-06-05 |
2013-11-26 | N/A | 2025-06-10 |
2013-12-03 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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 hav | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 i | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 twent | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 mutatio | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 suspicio | DRUG: Secretin
|
| 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 | DRUG: Secretin
|
| 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) | DRUG: Secretin
DIAGNOSTIC_TEST: MRI
OTHER: Tumor marker gene test with CA19-9
|
| 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 | DRUG: Secretin
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluate pancreatic juice for early cancer markers. | 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. | 10 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Compare pancreas juice with pancreas cyst fluid | Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance. | 10 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hilary Cosby, RN Phone Number: Email: hcosby1@jhmi.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
