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

Launched by M.D. ANDERSON CANCER CENTER · Oct 18, 2024

Keywords

ClinConnect Summary

The INSPPIRE 2 Study is a clinical trial aimed at understanding genetic factors that may increase the risk of pancreatic cancer in children. Specifically, it collects samples like blood, saliva, urine, or stool from young patients who have experienced conditions such as acute recurrent pancreatitis (which involves repeated episodes of severe abdominal pain) or chronic pancreatitis (a long-lasting condition that can cause permanent damage to the pancreas). By studying these samples, researchers hope to identify gene mutations that could help find children at higher risk for developing pancreatic cancer in the future.

To participate in this study, children under the age of 18 who have been diagnosed with either acute recurrent pancreatitis or chronic pancreatitis may be eligible. Parents or guardians will need to give consent for their child's participation and share their child's health information. Participants can expect to provide samples, and this research aims to contribute to better understanding and potentially improved screening for pancreatic cancer in children. It's important to know that children with serious medical conditions that cannot be managed properly will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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