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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,600
Undergo collection of blood, saliva, urine or stool samples
Complete QoL assessment
Complete questionnaire
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUCSF Benioff Children's Hospital Oakland
Oakland, California, United States
RECRUITINGStanford Cancer Institute Palo Alto
Palo Alto, California, United States
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.
Time frame: 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.
Time frame: Up to 4 years
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University of Colorado
Denver, Colorado, United States
RECRUITINGEmory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGRiley Hospital for Children
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
RECRUITINGOchsner Medical Center Jefferson
New Orleans, Louisiana, United States
RECRUITINGJohns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
RECRUITING...and 16 more locations