Screening for pancreatic cancer in high-risk individuals
The Cancer of the Pancreas Screening-5 CAPS5)Study
This study is testing different ways to check for early signs of pancreatic cancer in people who are at high risk due to genetic factors.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 9000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 9 sites (New Haven, Connecticut and 8 other locations) |
| Trial ID | NCT02000089 on ClinicalTrials.gov |
What this trial studies
This study aims to screen individuals at high risk for pancreatic cancer, including those with hereditary conditions such as Peutz-Jeghers Syndrome and specific gene mutations. Participants will undergo interventions including secretin administration, MRI scans, and tumor marker gene tests to identify early signs of cancer. The study is monitored by a quality assurance group to ensure safety and compliance with protocols. The goal is to improve early detection and outcomes for those predisposed to pancreatic cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with hereditary pancreatitis, Peutz-Jeghers Syndrome, or confirmed germline mutation carriers with a strong family history of pancreatic cancer.
Not a fit: Patients with significant medical comorbidities, prior surgeries that hinder endoscopic procedures, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer in high-risk patients, potentially improving survival rates.
How similar studies have performed: Other studies focusing on early detection in high-risk populations have shown promise, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut and 8 other locations
- 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)
Study contacts
- Principal investigator: Michael Goggins, MD — Johns Hopkins University
- Study coordinator: Hilary Cosby, RN
- Email: hcosby1@jhmi.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.