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NCT02000089PHASE3Recruiting

The Cancer of the Pancreas Screening-5 CAPS5)Study

Johns Hopkins University

Start Date

1/6/2014

Completion Date

6/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Secretin

DIAGNOSTIC_TEST

MRI

OTHER

Tumor marker gene test with CA19-9

Interested in This Trial?

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Conditions

Pancreas CancerPeutz-Jeghers Syndrome (PJS)Gene MutationGermline Mutation CarrierLynch Syndrome

Locations

Yale University

New Haven, Connecticut 06520

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Dana Farber Cancer Center, Harvard University

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

NYU Langone Medical Center

New York, New York 10016

United States

Columbia University Medical Center

New York, New York 10032

United States

Case Comprehensive Cancer Center, Case Western Medical Reserve

Cleveland, Ohio 44106

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States