The Cancer of the Pancreas Screening-5 CAPS5)Study

Trial ID: NCT02000089

Interventional - Phase 3 - Recruiting

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.

Conditions

• Pancreas Cancer
• Peutz-Jeghers Syndrome (PJS)
• Gene Mutation
• Germline Mutation Carrier
• Lynch Syndrome

Interventions

• Secretin
• MRI
• Tumor marker gene test with CA19-9

Eligibility

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.

Sponsor

Johns Hopkins University, National Cancer Institute (NCI), National Institutes of Health (NIH), American Association for Cancer Research

Source: ClinicalTrials.gov

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