Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
Recruiting · NCT06651580 · Observational (researchers observe without assigning treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionQuality-of-Life AssessmentQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
Up to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
26 locations listed across 14 US states.
- Children's Hospital Los Angeles - Los Angeles, California, United States
- Cedars Sinai Medical Center - Los Angeles, California, United States
- UCSF Benioff Children's Hospital Oakland - Oakland, California, United States
- Stanford Cancer Institute Palo Alto - Palo Alto, California, United States
- University of Colorado - Denver, Colorado, United States
- Emory University Hospital/Winship Cancer Institute - Atlanta, Georgia, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City, Iowa, United States
- Ochsner Medical Center Jefferson - New Orleans, Louisiana, United States
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore, Maryland, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- University of Minnesota/Masonic Children's Hospital - Minneapolis, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- Nationwide Children's Hospital - Columbus, Ohio, United States
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh, Pennsylvania, United States
- University of Texas Southwestern/Children's Medical Center - Dallas, Texas, United States
- M D Anderson Cancer Center - Houston, Texas, United States
- Texas Children's Hospital - Houston, Texas, United States
- Children's Hospital of San Antonio - San Antonio, Texas, United States
- Children's Hospital of Wisconsin - Milwaukee, Wisconsin, United States
- Hadassah University Hospital - Jerusalem, Israel
- Sydney Children's Hospital - Randwick, New South Wales, Australia
- Hospital for Sick Children - Toronto, Ontario, Canada
- The Montreal Children's Hospital of the MUHC - Montreal, Quebec, Canada