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The Cancer of the Pancreas Screening-5 (CAPS5) study


Primary Investigator
Stoffel, Elena
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT02000089
UM Number
2019.047
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Cancer Control and Prevention
ID (Protocol)
16133
Secondary Protocol No
HUM00161281
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed

Disease Site
Pancreas

Summary
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.

Eligibility: 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, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  •   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.