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.
Eligibility
Sex
ALL
Min age
—
Max age
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
Primary outcome measure(s)
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.
Trial sites (26)
Facility
City
Region
Status
Children's Hospital Los Angeles
Los Angeles
California
Recruiting
Cedars Sinai Medical Center
Los Angeles
California
Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland
California
Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto
California
Recruiting
University of Colorado
Denver
Colorado
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
Recruiting
Riley Hospital for Children
Indianapolis
Indiana
Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Iowa
Recruiting
Ochsner Medical Center Jefferson
New Orleans
Louisiana
Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Maryland
Recruiting
Boston Children's Hospital
Boston
Massachusetts
Recruiting
University of Minnesota/Masonic Children's Hospital
Minneapolis
Minnesota
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati
Ohio
Recruiting
Nationwide Children's Hospital
Columbus
Ohio
Recruiting
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Pennsylvania
Recruiting
University of Texas Southwestern/Children's Medical Center
Dallas
Texas
Recruiting
M D Anderson Cancer Center
Houston
Texas
Recruiting
Texas Children's Hospital
Houston
Texas
Recruiting
Children's Hospital of San Antonio
San Antonio
Texas
Recruiting
Children's Hospital of Wisconsin
Milwaukee
Wisconsin
Recruiting
Sydney Children's Hospital
Randwick
New South Wales
Recruiting
Hospital for Sick Children
Toronto
Ontario
Recruiting
The Montreal Children's Hospital of the MUHC
Montreal
Quebec
Recruiting
Hadassah University Hospital
Jerusalem
Israel
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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