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

RecruitingObservational study

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Who can join

Up to age 17 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: M.D. Anderson Cancer Center · Participants: 1,600 · Started: Apr 1, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT06651580

Locations in the U.S.

CaliforniaCedars Sinai Medical Center, Los Angeles
Children's Hospital Los Angeles, Los Angeles
UCSF Benioff Children's Hospital Oakland, Oakland
Stanford Cancer Institute Palo Alto, Palo Alto
ColoradoUniversity of Colorado, Denver
GeorgiaEmory University Hospital/Winship Cancer Institute, Atlanta
IndianaRiley Hospital for Children, Indianapolis
IowaUniversity of Iowa/Holden Comprehensive Cancer Center, Iowa City
LouisianaOchsner Medical Center Jefferson, New Orleans
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
MassachusettsBoston Children's Hospital, Boston
MinnesotaUniversity of Minnesota/Masonic Children's Hospital, Minneapolis
MissouriWashington University School of Medicine, St Louis
OhioCincinnati Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital, Columbus
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
TexasUniversity of Texas Southwestern/Children's Medical Center, Dallas
M D Anderson Cancer Center, Houston
Texas Children's Hospital, Houston
Children's Hospital of San Antonio, San Antonio
WisconsinChildren's Hospital of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.