Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
M.D. Anderson Cancer Center
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.
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 ever…
Eligibility
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
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 lipas…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood, saliva, urine or stool samples
- OtherQuality-of-Life Assessment
Complete QoL assessment
- OtherQuestionnaire Administration
Complete questionnaire
Locations (26)
- Children's Hospital Los AngelesLos Angeles, California
- Cedars Sinai Medical CenterLos Angeles, California
- UCSF Benioff Children's Hospital OaklandOakland, California
- Stanford Cancer Institute Palo AltoPalo Alto, California
- University of ColoradoDenver, Colorado
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia