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Recruiting NCT06651580

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

— Observational Chronic Pancreatitis Exocrine Pancreas Carcinoma Recurrent Acute Pancreatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis. Basic parameters: up to 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

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.

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of blood, saliva, urine or stool samples
  • Other Quality-of-Life Assessment
    Complete QoL assessment
  • Other Questionnaire Administration
    Complete questionnaire

Primary outcome measures

  • Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) [Time frame: Up to 4 years]
  • Risk factors that predispose children to CP sequelae and high disease burden [Time frame: Up to 4 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 22 centers
  • Children's Hospital Los Angeles — Los Angeles
  • Cedars Sinai Medical Center — Los Angeles
  • UCSF Benioff Children's Hospital Oakland — Oakland
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • University of Colorado — Denver
  • Emory University Hospital/Winship Cancer Institute — Atlanta
  • Riley Hospital for Children — Indianapolis
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City
  • … and 14 more centers
Canada · 2 centers
  • Hospital for Sick Children — Toronto
  • The Montreal Children's Hospital of the MUHC — Montreal
Australia · 1 center
  • Sydney Children's Hospital — Randwick
Israel · 1 center
  • Hadassah University Hospital — Jerusalem

Identifiers

NCT: NCT06651580 · 2020-1057 · NCI-2021-04028 · 2020-1057 · P30CA016672

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗