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)
3 other identifiers
observational
1,600
4 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
March 4, 2026
March 1, 2026
5.8 years
October 18, 2024
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP)
Two-sample t-test or Wilcoxon rank-sum test will be used for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest differences between ARP and CP (p value \< 0.15) will be included as independent variables in a multivariable logistic regression analysis for CP progression.
Up to 4 years
Risk factors that predispose children to CP sequelae and high disease burden
A two-sample t-test or Wilcoxon rank-sum test for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest an association with sequelae/disease burden (p-value \< 0.15) will be included as independent variables in a regression model for sequelae/disease burden. Normal/logistic/multinomial regression model will be used for continuous/binary/ordinal disease burden and sequelae outcomes. For repeated measures, random effects will be added to these models to account for correlation among the measures.
Up to 4 years
Study Arms (1)
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.
Interventions
Undergo collection of blood, saliva, urine or stool samples
Complete QoL assessment
Complete questionnaire
Eligibility Criteria
Pediatric patients (under 18 years) enrolled in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years.
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
- 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
- +1 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (26)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of Colorado
Denver, Colorado, 80217-3364, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota/Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
University of Texas Southwestern/Children's Medical Center
Dallas, Texas, 75235, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3, Canada
Hadassah University Hospital
Jerusalem, 91120, Israel
Biospecimen
Blood, saliva, urine, or stool samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Yuan, PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2024
First Posted
October 21, 2024
Study Start
April 1, 2021
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03