← Back to searchRecruitingRecruiting
Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
NCT06651580 · M.D. Anderson Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
About this study
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.
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
Study design
Enrollment target: 1600 participants
Age groups: child
Timeline
Starts: 2021-04-01
Estimated completion: 2027-02-02
Last updated: 2026-03-04
Interventions
Procedure: Biospecimen CollectionOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Primary outcomes
- • Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) (Up to 4 years)
- • Risk factors that predispose children to CP sequelae and high disease burden (Up to 4 years)
Sponsor
M.D. Anderson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactYing Yuan, PHD · contact · yyuan@mdanderson.org · (713) 563-4271
InvestigatorYing Yuan, PHD · principal_investigator, M.D. Anderson Cancer Center
All locations (26)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States
Cedars Sinai Medical CenterRecruiting
Los Angeles, California, United States
UCSF Benioff Children's Hospital OaklandRecruiting
Oakland, California, United States
Stanford Cancer Institute Palo AltoRecruiting
Palo Alto, California, United States
University of ColoradoRecruiting
Denver, Colorado, United States
Emory University Hospital/Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
Ochsner Medical Center JeffersonRecruiting
New Orleans, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
Baltimore, Maryland, United States
Boston Children's HospitalRecruiting
Boston, Massachusetts, United States
University of Minnesota/Masonic Children's HospitalRecruiting
Minneapolis, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern/Children's Medical CenterRecruiting
Dallas, Texas, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Children's HospitalRecruiting
Houston, Texas, United States
Children's Hospital of San AntonioRecruiting
San Antonio, Texas, United States
Children's Hospital of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Sydney Children's HospitalRecruiting
Randwick, New South Wales, Australia
Hospital for Sick ChildrenRecruiting
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHCRecruiting
Montreal, Quebec, Canada
Hadassah University HospitalRecruiting
Jerusalem, Israel