Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
Purpose
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
Eligibility
- Eligible Ages
- Under 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90027
Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
UCSF Benioff Children's Hospital Oakland
Oakland 5378538, California 5332921 94609
Oakland 5378538, California 5332921 94609
Stanford Cancer Institute Palo Alto
Palo Alto 5380748, California 5332921 94304
Palo Alto 5380748, California 5332921 94304
University of Colorado
Denver 5419384, Colorado 5417618 80217-3364
Denver 5419384, Colorado 5417618 80217-3364
Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Indianapolis 4259418, Indiana 4921868 46202
University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
Ochsner Medical Center Jefferson
New Orleans 4335045, Louisiana 4331987 70121
New Orleans 4335045, Louisiana 4331987 70121
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
University of Minnesota/Masonic Children's Hospital
Minneapolis 5037649, Minnesota 5037779 55454
Minneapolis 5037649, Minnesota 5037779 55454
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418 43205
Columbus 4509177, Ohio 5165418 43205
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927 15224
Pittsburgh 5206379, Pennsylvania 6254927 15224
University of Texas Southwestern/Children's Medical Center
Dallas 4684888, Texas 4736286 75235
Dallas 4684888, Texas 4736286 75235
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Texas Children's Hospital
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Children's Hospital of San Antonio
San Antonio 4726206, Texas 4736286 78207
San Antonio 4726206, Texas 4736286 78207
Contact:
Adam Noel
205-704-4515
Adam Noel
205-704-4515
Children's Hospital of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
More Details
- NCT ID
- NCT06651580
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
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.