The Cancer of the Pancreas Screening-5 CAPS5)Study

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: ChiRhoClin, Inc.; National Cancer Institute (NCI)
• Treatments: Pancreatin; Pancrelipase; Secretin

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, 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.