NCT06651580

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

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Detailed description

PRIMARY OBJECTIVE: I. To comprehensively characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) and determine predictors of early onset CP and its sequelae. OUTLINE: Patients complete quality-of-life (QoL) assessment and complete questionnaires for over 2 hours every 12 months for 4 years. Patients also undergo collection of blood and/or saliva (if blood samples are not available), urine, or stool at baseline or follow-up (if inadequate samples collected or missed at baseline). After completion of the study, patients are followed up every 12 months.

Conditions

• Chronic Pancreatitis
• Exocrine Pancreas Carcinoma
• Recurrent Acute Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood, saliva, urine or stool samples
OTHER	Quality-of-Life Assessment	Complete QoL assessment
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2021-04-01
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2024-10-21
• Last updated: 2026-03-04

Locations

26 sites across 4 countries: United States, Australia, Canada, Israel