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

Inclusion Criteria:

• All subjects/parents must sign an informed consent and/or assent indicating thatthey are aware of the investigational nature of this study

• Subjects/parents must have signed an authorization for the release of their or theirchild'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 definedbelow:

• 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 inflammatorychanges, and fluid collections

• ARP is defined as: At least 2 episodes of acute pancreatitis with completeresolution 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 withoutabdominal pain +/- exocrine pancreatic insufficiency +/- diabetes

• Irreversible structural changes:

• Ductal calculi, dilated side branches, parenchymalcalcifications found in any imaging (abdominal ultrasound [abd US], magnetic resonance imaging/magnetic resonancecholangiopancreatography [MRI/MRCP], computerizedtomography [CT], endoscopic retrogradecholangiopancreatography [ERCP], endoscopic US [EUS])

• Ductal obstruction or stricture/dilatation/irregularitiesthat are persistent (for >= 2 months) on any imaging

• Parenchymal atrophy, irregular contour, accentuated lobulararchitecture, cavities alone are not diagnostic findingsfor CP

• Surgical or pancreatic biopsy specimen demonstratinghistopathologic features compatible with CP (acinaratrophy, fibrosis, protein plugs, infiltration withlymphocytes, plasma cells, macrophages)

Exclusion Criteria:

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