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.
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
Abdominal pain compatible with AP
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
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.
Cohort
Prospective
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, saliva, urine or stool samples
Quality-of-Life Assessment
Other interventionComplete QoL assessment
Questionnaire Administration
Other interventionComplete questionnaire
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.
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.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator