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Pancreas CancerGeneticsDiagnostics and screeningCancerWomen's healthDrugDiagnostic testPhase 3

What this study is

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.

What's being tested

  • Secretin

    Intervention · DRUG

    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.

  • MRI

    Intervention · DIAGNOSTIC TEST

    MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.

  • Tumor marker gene test with CA19-9

    Intervention · OTHER

    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.

Study details

Sponsor
Johns Hopkins University
Conditions
Pancreas Cancer · Peutz-Jeghers Syndrome (PJS) · Gene Mutation · Germline Mutation Carrier · Lynch Syndrome
Enrolling
9,000 people
Starts
2014-01-06
Est. completion
2029-06
Design
Open-label, non-randomized, single group, Phase 3
Record
View on ClinicalTrials.gov ↗