CAPS5 Study: Screening for Pancreatic Cancer in High-Risk Individuals

This study, called CAPS5, is looking for early signs of pancreatic cancer in people who have a higher risk of developing it. Researchers will use Secretin (a drug injected to stimulate pancreatic fluid) and collect this fluid to check for biomarkers (substances that can indicate disease). They will also use MRI (a type of imaging scan) if certain blood test results (CA-19-9) are abnormal, and a special gene test for CA-19-9 to understand individual levels. The study aims to find early cancer markers in pancreatic fluid over 10 years. You might be able to join if you are 18 or older and have conditions like hereditary pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, or a confirmed gene mutation (like BRCA1, BRCA2, or Lynch Syndrome).

Study design
This is an interventional study with a planned enrollment of 9000 participants. It is not specified if it's randomized or blinded.
What's involved
You would receive an injection of Secretin, have pancreatic fluid collected, and potentially undergo an MRI abdomen with contrast. A tumor marker gene test for CA19-9 will also be performed.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate pancreatic juice for early cancer markers over 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02000089

The Cancer of the Pancreas Screening-5 CAPS5)Study

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Johns Hopkins University
~9,000 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:SecretinMRITumor marker gene test with CA19-9

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate pancreatic juice for early cancer markers.
Measured over 10 years
Pancreas Cancer
Peutz-Jeghers Syndrome (PJS)
Gene Mutation
Germline Mutation Carrier
Lynch Syndrome
9 sites across 7 states
New York2
Pennsylvania2
Connecticut1
Maryland1
Massachusetts1
Michigan1
Ohio1
  • Michael Goggins, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Evaluate pancreatic juice for early cancer markers.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.