RECRUITING

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

Conditions

Chronic Pancreatitis Exocrine Pancreas Carcinoma Recurrent Acute Pancreatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Quick Facts

Study Start:2021-04-01

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06651580

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.

Ages Eligible for Study:Not specified to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Ying Yuan, PHD

CONTACT

(713) 563-4271

yyuan@mdanderson.org

Principal Investigator

Ying Yuan, PHD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

United States

University of Colorado

Denver, Colorado, 80217-3364

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Minnesota/Masonic Children's Hospital

Minneapolis, Minnesota, 55454

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

University of Texas Southwestern/Children's Medical Center

Dallas, Texas, 75235

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-01

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Chronic Pancreatitis
Exocrine Pancreas Carcinoma
Recurrent Acute Pancreatitis