Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Children's Hospital Los Angeles
RECRUITING
Los Angeles
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
Stanford Cancer Institute Palo Alto
RECRUITING
Palo Alto
Colorado
University of Colorado
RECRUITING
Denver
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Iowa
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Louisiana
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Minnesota
University of Minnesota/Masonic Children's Hospital
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Texas
University of Texas Southwestern/Children's Medical Center
RECRUITING
Dallas
M D Anderson Cancer Center
RECRUITING
Houston
Texas Children's Hospital
RECRUITING
Houston
Children's Hospital of San Antonio
RECRUITING
San Antonio
Wisconsin
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Sydney Children's Hospital
RECRUITING
Randwick
Canada
The Montreal Children's Hospital of the MUHC
RECRUITING
Montreal
Hospital for Sick Children
RECRUITING
Toronto
Israel
Hadassah University Hospital
RECRUITING
Jerusalem
Contact Information
Primary
Ying Yuan, PHD
yyuan@mdanderson.org
(713) 563-4271
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 1600
Treatments
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.
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov