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The Cancer of the Pancreas Screening-5 CAPS5)Study

NCT02000089 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9000

Last updated 2025-10-09

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Goggins, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-06
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000089 on ClinicalTrials.gov