Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study

Open to people ages up to 17 years

• All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
• Subjects/parents must have signed an authorization for the release of their or their child's protected health information
• All children must be under 18 years of age at the time of enrollment
• All children providing samples should fit the ARP or CP inclusion criteria defined below:
  • Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
    • Abdominal pain compatible with AP
    • Serum amylase and/or lipase values >= 3 times upper limits of normal
    • Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
  • ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a >= 1 month pain-free interval between episodes
  • Chronic Pancreatitis:

    • Children with at least:

      - One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes - Irreversible structural changes: - Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound [abd US], magnetic resonance imaging/magnetic resonance cholangiopancreatography [MRI/MRCP], computerized tomography [CT], endoscopic retrograde cholangiopancreatography [ERCP], endoscopic US [EUS]) - Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >= 2 months) on any imaging - Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP - Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)

• Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions