The Cancer of the Pancreas Screening-5 CAPS5)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.

Interventions

• Secretin · 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 · 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 · 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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 (CDKN2A/p16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR
* 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.

Sites (9)

• Yale University, New Haven, Connecticut · RECRUITING
• Johns Hopkins Hospital, Baltimore, Maryland · RECRUITING
• Dana Farber Cancer Center, Harvard University, Boston, Massachusetts · RECRUITING
• University of Michigan, Ann Arbor, Michigan · RECRUITING
• NYU Langone Medical Center, New York, New York · RECRUITING
• Columbia University Medical Center, New York, New York · RECRUITING
• Case Comprehensive Cancer Center, Case Western Medical Reserve, Cleveland, Ohio · RECRUITING
• University of Pennsylvania, Philadelphia, Pennsylvania · RECRUITING
• University of Pittsburgh, Pittsburgh, Pennsylvania · RECRUITING