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

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

M.D. Anderson Cancer Center · NCT06651580

This study is trying to find out if certain gene changes in children with pancreatitis can help us understand their risk of getting pancreatic cancer later on.

Quick facts

Study typeObservational
Enrollment1600 (estimated)
AgesN/A to 17 Years
SexAll
SponsorM.D. Anderson Cancer Center (other)
Locations26 sites (Los Angeles, California and 25 other locations)
Trial IDNCT06651580 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are children under 18 years of age who have been diagnosed with acute recurrent pancreatitis or chronic pancreatitis.

Not a fit: Patients who do not have acute recurrent pancreatitis or chronic pancreatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to early identification of pediatric patients at high risk for pancreatic cancer, allowing for timely interventions.

How similar studies have performed: Other studies have shown promise in identifying genetic markers for pancreatic cancer, but this specific approach in pediatric patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.