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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-04028 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1057 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, saliva, urine or stool samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pediatric population with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) | Two-sample t-test or Wilcoxon rank-sum test will be used for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest differences between ARP and CP (p value < 0.15) will be included as independent variables in a multivariable logistic regression analysis for CP progression. | Up to 4 years |
| Risk factors that predispose children to CP sequelae and high disease burden | A two-sample t-test or Wilcoxon rank-sum test for the continuous/ordinal variables and Pearson Chi-square test for the categorical variables. The variables that suggest an association with sequelae/disease burden (p-value < 0.15) will be included as independent variables in a regression model for sequelae/disease burden. Normal/logistic/multinomial regression model will be used for continuous/binary/ordinal disease burden and sequelae outcomes. For repeated measures, random effects will be added to these models to account for correlation among the measures. | Up to 4 years |
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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:
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:
Exclusion Criteria:
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Pediatric patients (under 18 years) enrolled in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Yuan, PHD | Contact | (713) 563-4271 | yyuan@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ying Yuan, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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Blood, saliva, urine, or stool samples
| Quality-of-Life Assessment | Other | Complete QoL assessment |
|
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| Questionnaire Administration | Other | Complete questionnaire |
|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| UCSF Benioff Children's Hospital Oakland | Recruiting | Oakland | California | 94609 | United States |
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| Stanford Cancer Institute Palo Alto | Recruiting | Palo Alto | California | 94304 | United States |
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| University of Colorado | Recruiting | Denver | Colorado | 80217-3364 | United States |
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| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| University of Iowa/Holden Comprehensive Cancer Center | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Ochsner Medical Center Jefferson | Recruiting | New Orleans | Louisiana | 70121 | United States |
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| Johns Hopkins University/Sidney Kimmel Cancer Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Minnesota/Masonic Children's Hospital | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Children's Hospital of Pittsburgh of UPMC | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| University of Texas Southwestern/Children's Medical Center | Recruiting | Dallas | Texas | 75235 | United States |
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| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| Children's Hospital of San Antonio | Recruiting | San Antonio | Texas | 78207 | United States |
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| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Sydney Children's Hospital | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| The Montreal Children's Hospital of the MUHC | Recruiting | Montreal | Quebec | H3H 1P3 | Canada |
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| Hadassah University Hospital | Recruiting | Jerusalem | 91120 | Israel |
|
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010190 | Pancreatic Neoplasms |
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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