NCT02000089 · Johns Hopkins University
The Cancer of the Pancreas Screening-5 CAPS5)Study
(CAPS5)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Secretin
inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers.
DIAGNOSTIC_TEST
MRI
MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
OTHER
Tumor marker gene test with CA19-9
A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9.
Primary outcome measures
Evaluate pancreatic juice for early cancer markers.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- New York, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations