The Cancer of the Pancreas Screening-5 CAPS5)Study
Recruiting · NCT02000089 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
MRISecretinTumor marker gene test with CA19-9
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
9 locations listed across 7 US states.
- Yale University - New Haven, Connecticut, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Dana Farber Cancer Center, Harvard University - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- NYU Langone Medical Center - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Case Comprehensive Cancer Center, Case Western Medical Reserve - Cleveland, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States