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

Description

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.

Conditions

Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis

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Study Overview

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Study Details

Study overview

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.

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

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

Condition
Chronic Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

Palo Alto

Stanford Cancer Institute Palo Alto, Palo Alto, California, United States, 94304

Denver

University of Colorado, Denver, Colorado, United States, 80217-3364

Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46202

Iowa City

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States, 52242

New Orleans

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States, 70121

Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Ying Yuan, PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-02-02