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RECRUITINGPhase 3INTERVENTIONAL

The Cancer of the Pancreas Screening-5 CAPS5)Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form - Pregnancy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (9)

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