Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
NCT ID: NCT06651580
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1600 participants
OBSERVATIONAL
2021-04-01
2027-02-02
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (biospecimen collection and questionnaire)
Patients complete 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.
Biospecimen Collection
Undergo collection of blood, saliva, urine or stool samples
Quality-of-Life Assessment
Complete QoL assessment
Questionnaire Administration
Complete questionnaire
Interventions
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Biospecimen Collection
Undergo collection of blood, saliva, urine or stool samples
Quality-of-Life Assessment
Complete QoL assessment
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ying Yuan, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
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
Hadassah University Hospital
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Adam Noel
Role: primary
Other Identifiers
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NCI-2021-04028
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1057
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1057
Identifier Type: -
Identifier Source: org_study_id
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