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The Cancer of the Pancreas Screening-5 (CAPS5) Study

  • Study HIC#:1408014448
  • Last Updated:07/15/2021

The purpose of the study is to evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls; to compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.

  • Age18 years and older
  • GenderBoth
  • Start Date05/12/2015
  • End Date10/31/2021

Trial Purpose and Description

Primary Outcome Measures:

  • Evaluate pancreatic juice for early cancer markers. [ Time Frame: 8 years ] [ Designated as safety issue: No ]Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.

Secondary Outcome Measures:

  • Compare pancreas juice with pancreas cyst fluid [ Time Frame: 8 years ] [ Designated as safety issue: No ]Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.

Other Outcome Measures:

  • Time disease progression and prevalence [ Time Frame: 8 years ] [ Designated as safety issue: No ]Aim #3: To determine the prevalence of pancreatic lesions, pancreatic fluid mutations and circulating pancreatic epithelial cells among a large cohort of high-risk individuals undergoing pancreatic screening and surveillance of a new cohort in which screening is begun at age >55.

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, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  • 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