RecruitingRecruiting
The Cancer of the Pancreas Screening-5 CAPS5)Study
NCT02000089 · Johns Hopkins University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility 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.
Study design
Enrollment target: 9000 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2014-01-06
Estimated completion: 2029-06
Last updated: 2025-10-09
Interventions
Drug: SecretinDiagnostic Test: MRIOther: Tumor marker gene test with CA19-9
Primary outcomes
- • Evaluate pancreatic juice for early cancer markers. (10 years)
Sponsor
Johns Hopkins University · other
With: National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research
Contacts & investigators
ContactHilary Cosby, RN · contact · hcosby1@jhmi.edu
InvestigatorMichael Goggins, MD · principal_investigator, Johns Hopkins University
All locations (9)
Yale UniversityRecruiting
New Haven, Connecticut, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer Center, Harvard UniversityRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
NYU Langone Medical CenterRecruiting
New York, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Case Comprehensive Cancer Center, Case Western Medical ReserveRecruiting
Cleveland, Ohio, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States