Recruiting

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

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06651580

Conditions

Chronic Pancreatitis

Exocrine Pancreas Carcinoma

Recurrent Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Chronic Pancreatitis

Exocrine Pancreas Carcinoma

Recurrent Acute Pancreatitis

Study ID

NCT06651580

Start date

Apr 1, 2021

Status verified date

Mar, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection and questionnaire)

Patients complete 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.

Interventions

Biospecimen Collection

Undergo collection of blood, saliva, urine or stool samples

Quality-of-Life Assessment

Complete QoL assessment

Questionnaire Administration

Complete questionnaire

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Ying Yuan, PHD

(713) 563-4271 yyuan@mdanderson.org

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Yuhua Zheng

323-361-4454 yzheng@chla.usc.edu

Principal Investigator:

Yuhua Zheng

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Quin Liu

310-423-6082 quin.liu@cshs.org

Principal Investigator:

Quin Liu

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Emily Perito

415-476-5892 emily.perito@ucsf.edu

Principal Investigator:

Emily Perito

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Zachary Sellers

650-497-8000 zsellers@stanford.edu

Principal Investigator:

Zachary Sellers

University of Colorado

Recruiting

Denver, Colorado, United States, 80217-3364

Contacts

Jacob Mark

720-777-6669 jacob.mark@childrenscolorado.org

Principal Investigator:

Jacob Mark

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Reuven Cohen, MD

404-785-5437 reuven.zev.cohen@emory.edu

Principal Investigator:

Reuven "Zev" Cohen

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Brian McFerron

317-944-3774 bmcferro@iu.edu

Principal Investigator:

Brian McFerron

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Aliye Uc

319-384-6032 aliye-uc@uiowa.edu

Principal Investigator:

Aliye Uc

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Matthew Giefer, MD

504-842-4021 matthew.giefer@ochsner.org

Principal Investigator:

Matthew Giefer

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Kenneth Ng

516-906-1716 kng13@jhmi.edu

Principal Investigator:

Kenneth Ng

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Amit Grover

617-619-4713 amit.grover@childrens.harvard.edu

Principal Investigator:

Amit Grover

University of Minnesota/Masonic Children's Hospital

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Elissa Downs, MD

612-624-1133 down@0015@umn.edu

Principal Investigator:

Elissa Downs

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Mark Lowe

314-286-2784 lowe@wustl.edu

Principal Investigator:

Mark Lowe

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Maisam Abu-El-Haija

513-803-2123 Maisam.Haija@cchmc.org

Principal Investigator:

Maisam Abu-El-Haija

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Cheryl Gariepy

614-722-8406 Cheryl.Gariepy@nationwidechildrens.org

Principal Investigator:

Cheryl Gariepy

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Asim Maqbool

215-590-3247 MAQBOOL@email.chop.edu

Principal Investigator:

Asim Maqbool

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Douglas Lindblad

412-946-2053 lindbladd@upmc.edu

Principal Investigator:

Douglas Lindblad

University of Texas Southwestern/Children's Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Megha Mehta, MD

972-979-2154 megha.mehta@utsouthwestern.edu

Principal Investigator:

Megha Mehta

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Suresh T. Chari

713-501-3714 STChari@mdanderson.org

Principal Investigator:

Suresh T. Chari

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Douglas Fishman

douglas.fishman@bcm.edu

Principal Investigator:

Douglas Fishman

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Adam Noel

205-704-4515

Principal Investigator:

Adam Noel

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Ankur Chugh, MD

414-266-4843 achugh@mcw.edu

Principal Investigator:

Ankur Chugh

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Tanja Gonska

416-813-2164 tanja.gonska@sickkids.ca

Principal Investigator:

Tanja Gonska

The Montreal Children's Hospital of the MUHC

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Contacts

Veronique Morinville

514-412-4400 veronique.morinville@mcgill.ca

Principal Investigator:

Veronique Morinville

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-04.