Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis
Conditions
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood, saliva, urine or stool samples
OTHERQuality-of-Life Assessment
Complete QoL assessment
OTHERQuestionnaire Administration
Complete questionnaire
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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 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 * Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) | 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 | 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. |
Countries
Australia, Canada, Israel, United States
Contacts
CONTACTYing Yuan, PHD
PRINCIPAL_INVESTIGATORYing Yuan, PHD
M.D. Anderson Cancer Center
Outcome results
None listed