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NCT06651580Recruiting

Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study

M.D. Anderson Cancer Center

Start Date

4/1/2021

Completion Date

2/2/2027

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.

Eligibility Criteria

Age Range: No minimum to 17 years

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

Interventions

PROCEDURE

Biospecimen Collection

OTHER

Quality-of-Life Assessment

OTHER

Questionnaire Administration

Interested in This Trial?

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Conditions

Chronic PancreatitisExocrine Pancreas CarcinomaRecurrent Acute Pancreatitis

Locations

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California 94609

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California 94304

United States

University of Colorado

Denver, Colorado 80217-3364

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa 52242

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland 21287

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

University of Minnesota/Masonic Children's Hospital

Minneapolis, Minnesota 55454

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania 15224

United States

University of Texas Southwestern/Children's Medical Center

Dallas, Texas 75235

United States

M D Anderson Cancer Center

Houston, Texas 77030

United States

Texas Children's Hospital

Houston, Texas 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas 78207

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin 53226

United States

Sydney Children's Hospital

Randwick, New South Wales 2031

Australia

Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec H3H 1P3

Canada

Hadassah University Hospital

Jerusalem, 91120

Israel