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Recruiting Phase 3 NCT02000089

The Cancer of the Pancreas Screening-5 CAPS5)Study

Trial Parameters

Condition Pancreas Cancer
Sponsor Johns Hopkins University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 9,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2014-01-06
Completion 2028-12
Interventions
SecretinMRITumor marker gene test with CA19-9

Brief 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.

Eligibility Criteria

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.

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