Collecting samples to identify gene mutations in children at risk for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect blood, saliva, urine, or stool samples from pediatric patients with acute recurrent pancreatitis and chronic pancreatitis to identify genetic mutations that may increase the risk of developing pancreatic cancer. Participants will complete quality-of-life assessments and questionnaires annually for four years, alongside biospecimen collection at baseline and follow-up visits. The study seeks to characterize the pediatric population affected by these conditions and determine predictors of early onset chronic pancreatitis and its complications.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UCSF Benioff Children's Hospital Oakland
  Oakland, California, United States Recruiting
• Stanford Cancer Institute Palo Alto
  Palo Alto, California, United States Recruiting
• University of Colorado
  Denver, Colorado, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Ying Yuan, PHD — M.D. Anderson Cancer Center
• Study coordinator: Ying Yuan, PHD
• Email: yyuan@mdanderson.org
• Phone: (713) 563-4271

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.