NCT02000089

The Cancer of the Pancreas Screening-5 CAPS5)Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,000 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pancreas Cancer
• Peutz-Jeghers Syndrome (PJS)
• Gene Mutation
• Germline Mutation Carrier
• Lynch Syndrome

Interventions

Type	Name	Description
DRUG	Secretin	inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers.
DIAGNOSTIC_TEST	MRI	MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.
OTHER	Tumor marker gene test with CA19-9	A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9.

Timeline

• Start date: 2014-01-06
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2013-12-03
• Last updated: 2025-10-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study