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

Recruiting now

Conditions studied: Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis

In brief

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.

Key facts

Study ID

NCT06651580

Run by

M.D. Anderson Cancer Center

People needed

1600

Starts

2021-04-01

Expected to finish

2027-02-02

Last updated by the study team

2026-03-04

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States (enrolling)
• University of Colorado — Denver, Colorado, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States (enrolling)
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Minnesota/Masonic Children's Hospital — Minneapolis, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Texas Southwestern/Children's Medical Center — Dallas, Texas, United States (enrolling)
• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Children's Hospital of San Antonio — San Antonio, Texas, United States (enrolling)
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Sydney Children's Hospital — Randwick, New South Wales, Australia (enrolling)
• Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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