Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
Overview
- Phase
- Not Applicable
- Intervention
- Biospecimen Collection
- Conditions
- Chronic Pancreatitis
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 1600
- Locations
- 26
- Primary Endpoint
- Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP)
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Detailed Description
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.
Investigators
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:
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
Arms & Interventions
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.
Intervention: Biospecimen Collection
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.
Intervention: Quality-of-Life Assessment
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.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP)
Time Frame: Up to 4 years
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
Time Frame: Up to 4 years
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.