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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03672422
Registration number
NCT03672422
Ethics application status
Date submitted
28/08/2018
Date registered
14/09/2018
Titles & IDs
Public title
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
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Scientific title
Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
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Secondary ID [1]
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3U01DK108334
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Secondary ID [2]
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201705709
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Universal Trial Number (UTN)
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Trial acronym
INSPPIRE 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatitis, Chronic
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Pancreatitis, Acute
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Blood sample
BEHAVIORAL - Patient questionnaires
Diagnosis / Prognosis - Saliva sample
Diagnosis / Prognosis - Urine sample
Acute Recurrent Pancreatitis - 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:
1) 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).
Diagnosis / Prognosis: Blood sample
Six ml of blood will be collected from patients in an EDTA tube. 2 ml saliva samples in Oragene DNA collection kits
BEHAVIORAL: Patient questionnaires
Questionnaires will be completed at the baseline and annual follow-up visits to collect data that will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.
Diagnosis / Prognosis: Saliva sample
2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected.
Diagnosis / Prognosis: Urine sample
50 ml of urine in collection container.
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Intervention code [1]
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Diagnosis / Prognosis
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Intervention code [2]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Length of time from progression from Acute Recurrent Pancreatitis to Chronic Pancreatitis
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Assessment method [1]
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Date of diagnosis of first acute pancreatitis to date of diagnosis of chronic pancreatitis presented as minimum, maximum, median number of days and no progression to chronic pancreatitis.
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Number of subjects with abdominal pain
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Assessment method [1]
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Presence of abdominal pain in the past year presented as number with "Yes", "No", "I don't know" and missing responses.
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Number of subjects with constant abdominal pain
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Assessment method [2]
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Presence of constant abdominal pain described as number of subjects with "Yes", "No", "I don't know" and missing responses.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Number of subjects with episodic abdominal pain
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Assessment method [3]
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Number of subjects who are usually pain free with episodes of abdominal pain described as number with "Yes", "No", "I don't know" and missing responses..
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Number of emergency room visits subject had in the past 12 months
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Assessment method [4]
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Number of emergency room visits subjects experienced in the past 12 months presented as minimum, maximum, and median number of emergency room visits and number of missing responses.
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Number of emergency room visits subject had in whole life
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Assessment method [5]
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Number of emergency room visits the subject experienced in their whole life presented as minimum, maximum, and median number of visits and number of missing responses..
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Timepoint [5]
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18 years
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Secondary outcome [6]
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Number of hospitalizations subject had in past 12 months
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Assessment method [6]
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Number of hospitalizations subject experienced in the past 12 months presented as minimum, maximum, and median number and number of missing responses..
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Timepoint [6]
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1 year
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Secondary outcome [7]
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Number of hospitalizations subject had in whole life
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Assessment method [7]
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Number of hospitalizations subject had in their whole life presented as minimum, maximum, and median number and number of missing responses..
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Timepoint [7]
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18 years
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Secondary outcome [8]
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Number of school days subject missed in the last month
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Assessment method [8]
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Number of school days subject missed in the last month presented as minimum, maximum, and median number and number of missing responses..
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Timepoint [8]
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30 days
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Secondary outcome [9]
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Number of subjects with Exocrine Pancreatic Insufficiency
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Assessment method [9]
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Number of subjects with abnormal fecal elastase (\< 100 micrograms/ gram of stool on 2 separate samples = 1 month apart) presented as number of subjects with abnormal and normal lab values and number of subjects who did not have test done.
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Timepoint [9]
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3 years
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Secondary outcome [10]
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Number of subjects with abnormal fasting glucose
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Assessment method [10]
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Number of subjects with fasting glucose =126 milligrams per deciliter presented as number of subjects with abnormal and normal lab value and number of subjects who did not have test done.
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Timepoint [10]
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3 years
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Secondary outcome [11]
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Number of subjects with abnormal hemoglobin A1c (HbA1c)
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Assessment method [11]
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Number of subjects with HbA1c (abnormal if \>6; diabetic if \>6.5%) results that were normal, abnormal, and diabetic and number who did not have test done.
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Timepoint [11]
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3 years
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Secondary outcome [12]
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Number of subjects with abnormal oral glucose tolerance test (OGTT)
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Assessment method [12]
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Number of subjects with abnormal OGTT test results. OGTT performed with 1.75 grams/kilogram of standard glucose beverage (glucola, maximum 75 grams) consumed within 10 minutes at time 0. Glucose drawn prior to the beverage and at time 120 minutes. Glycemic status will be defined as: (1) normal glucose tolerance (NGT, fasting glucose \<100 mg/dL, 2 hour \<140 mg/dL); (2) pre-diabetic based on impaired fasting glucose (IFG, fasting glucose 100-125 mg/dL) and/or impaired glucose tolerance (IGT, 2 hour glucose 140-199 mg/dL); or (3) diabetic (DM, fasting glucose \>126 mg/dL or 2 hour glucose \>200 mg/dL). Findings presented as number of subjects with normal, pre-diabetic, impaired, and diabetic results and number that did not have test done.
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Timepoint [12]
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3 years
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Eligibility
Key inclusion criteria
1. All patients/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study.
2 Patients/parents must have signed an authorization for the release of their or their child's protected health information.
3 All children providing samples should fit the ARP or CP inclusion criteria defined below.
4 All children must be under 18 years of age at the time of enrollment.
Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
1. Abdominal pain compatible with AP,
2. Serum amylase and/or lipase values =3 times upper limits of normal,
3. 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:
1. 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).
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Minimum age
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study interventions.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2020
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Sample size
Target
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Accrual to date
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Final
623
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Children's Hospital Randwick - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Indiana
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Country [3]
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United States of America
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State/province [3]
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Iowa
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Country [4]
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United States of America
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State/province [4]
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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
0
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United States of America
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State/province [7]
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Ohio
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
0
0
United States of America
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State/province [9]
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Texas
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Country [10]
0
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United States of America
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State/province [10]
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Utah
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Country [11]
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United States of America
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State/province [11]
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Washington
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Country [12]
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United States of America
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State/province [12]
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Wisconsin
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Country [13]
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Canada
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State/province [13]
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Ontario
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Country [14]
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Canada
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State/province [14]
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Quebec
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Country [15]
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Israel
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State/province [15]
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Jerusalem
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Funding & Sponsors
Primary sponsor type
Other
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Name
Aliye Uc
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Address [1]
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Other collaborator category [2]
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Government body
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Name [2]
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National Cancer Institute (NCI)
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.
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Trial website
https://clinicaltrials.gov/study/NCT03672422
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Trial related presentations / publications
Abu-El-Haija M, Kumar S, Quiros JA, Balakrishnan K, Barth B, Bitton S, Eisses JF, Foglio EJ, Fox V, Francis D, Freeman AJ, Gonska T, Grover AS, Husain SZ, Kumar R, Lapsia S, Lin T, Liu QY, Maqbool A, Sellers ZM, Szabo F, Uc A, Werlin SL, Morinville VD. Management of Acute Pancreatitis in the Pediatric Population: A Clinical Report From the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Pancreas Committee. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):159-176. doi: 10.1097/MPG.0000000000001715. Abu-El-Haija M, Uc A, Werlin SL, Freeman AJ, Georgieva M, Jojkic-Pavkov D, Kalnins D, Kochavi B, Koot BGP, Van Biervliet S, Walkowiak J, Wilschanski M, Morinville VD. Nutritional Considerations in Pediatric Pancreatitis: A Position Paper from the NASPGHAN Pancreas Committee and ESPGHAN Cystic Fibrosis/Pancreas Working Group. J Pediatr Gastroenterol Nutr. 2018 Jul;67(1):131-143. doi: 10.1097/MPG.0000000000002023. Morinville VD, Husain SZ, Bai H, Barth B, Alhosh R, Durie PR, Freedman SD, Himes R, Lowe ME, Pohl J, Werlin S, Wilschanski M, Uc A; INSPPIRE Group. Definitions of pediatric pancreatitis and survey of present clinical practices. J Pediatr Gastroenterol Nutr. 2012 Sep;55(3):261-5. doi: 10.1097/MPG.0b013e31824f1516. Erratum In: J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):459. Abu-Al-Haija, Maisam [corrected to Abu-El-Haija, Maisam]. Morinville VD, Lowe ME, Ahuja M, Barth B, Bellin MD, Davis H, Durie PR, Finley B, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Heyman MB, Himes R, Husain S, Kumar S, Ooi CY, Pohl JF, Schwarzenberg SJ, Troendle D, Werlin SL, Wilschanski M, Yen E, Uc A. Design and implementation of INSPPIRE. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):360-4. doi: 10.1097/MPG.0000000000000417. Perito ER, Rhee S. Relief for Young Children With Severe Chronic Pancreatitis. J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):338-339. doi: 10.1097/MPG.0000000000001509. No abstract available. Uc A, Andersen DK, Bellin MD, Bruce JI, Drewes AM, Engelhardt JF, Forsmark CE, Lerch MM, Lowe ME, Neuschwander-Tetri BA, O'Keefe SJ, Palermo TM, Pasricha P, Saluja AK, Singh VK, Szigethy EM, Whitcomb DC, Yadav D, Conwell DL. Chronic Pancreatitis in the 21st Century - Research Challenges and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop. Pancreas. 2016 Nov;45(10):1365-1375. doi: 10.1097/MPA.0000000000000713. Uc A, Fishman DS. Pancreatic Disorders. Pediatr Clin North Am. 2017 Jun;64(3):685-706. doi: 10.1016/j.pcl.2017.01.010. Gariepy CE, Heyman MB, Lowe ME, Pohl JF, Werlin SL, Wilschanski M, Barth B, Fishman DS, Freedman SD, Giefer MJ, Gonska T, Himes R, Husain SZ, Morinville VD, Ooi CY, Schwarzenberg SJ, Troendle DM, Yen E, Uc A. Causal Evaluation of Acute Recurrent and Chronic Pancreatitis in Children: Consensus From the INSPPIRE Group. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):95-103. doi: 10.1097/MPG.0000000000001446. Giefer MJ, Lowe ME, Werlin SL, Zimmerman B, Wilschanski M, Troendle D, Schwarzenberg SJ, Pohl JF, Palermo J, Ooi CY, Morinville VD, Lin TK, Husain SZ, Himes R, Heyman MB, Gonska T, Gariepy CE, Freedman SD, Fishman DS, Bellin MD, Barth B, Abu-El-Haija M, Uc A. Early-Onset Acute Recurrent and Chronic Pancreatitis Is Associated with PRSS1 or CTRC Gene Mutations. J Pediatr. 2017 Jul;186:95-100. doi: 10.1016/j.jpeds.2017.03.063. Epub 2017 May 10. Erratum In: J Pediatr. 2018 Dec;203:468-469. doi: 10.1016/j.jpeds.2018.08.026. Husain SZ, Morinville V, Pohl J, Abu-El-Haija M, Bellin MD, Freedman S, Hegyi P, Heyman MB, Himes R, Ooi CY, Schwarzenberg SJ, Usatin D, Uc A. Toxic-metabolic Risk Factors in Pediatric Pancreatitis: Recommendations for Diagnosis, Management, and Future Research. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):609-17. doi: 10.1097/MPG.0000000000001035. Kumar S, Ooi CY, Werlin S, Abu-El-Haija M, Barth B, Bellin MD, Durie PR, Fishman DS, Freedman SD, Gariepy C, Giefer MJ, Gonska T, Heyman MB, Himes R, Husain SZ, Lin TK, Lowe ME, Morinville V, Palermo JJ, Pohl JF, Schwarzenberg SJ, Troendle D, Wilschanski M, Zimmerman MB, Uc A. Risk Factors Associated With Pediatric Acute Recurrent and Chronic Pancreatitis: Lessons From INSPPIRE. JAMA Pediatr. 2016 Jun 1;170(6):562-9. doi: 10.1001/jamapediatrics.2015.4955. Lin TK, Abu-El-Haija M, Nathan JD, Palermo JP, Barth B, Bellin M, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Heyman MB, Himes R, Husain SZ, Liu Q, Maqbool A, Mascarenhas M, McFerron B, Morinville VD, Ooi CY, Perito E, Pohl JF, Rhee S, Schwarzenberg SJ, Shah U, Troendle D, Werlin SL, Wilschanski M, Zimmerman MB, Lowe ME, Uc A. Pancreas Divisum in Pediatric Acute Recurrent and Chronic Pancreatitis: Report From INSPPIRE. J Clin Gastroenterol. 2019 Jul;53(6):e232-e238. doi: 10.1097/MCG.0000000000001063. Pohl J, Morinville V, Husain SZ, Uc A. Toxic-Metabolic Risk Factors Are Uncommon in Pediatric Chronic Pancreatitis. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):e66-7. doi: 10.1097/MPG.0000000000001156. No abstract available. Scheers I, Palermo JJ, Freedman S, Wilschanski M, Shah U, Abu-El-Haija M, Barth B, Fishman DS, Gariepy C, Giefer MJ, Heyman MB, Himes RW, Husain SZ, Lin TK, Liu Q, Lowe M, Mascarenhas M, Morinville V, Ooi CY, Perito ER, Piccoli DA, Pohl JF, Schwarzenberg SJ, Troendle D, Werlin S, Zimmerman B, Uc A, Gonska T. Recommendations for Diagnosis and Management of Autoimmune Pancreatitis in Childhood: Consensus From INSPPIRE. J Pediatr Gastroenterol Nutr. 2018 Aug;67(2):232-236. doi: 10.1097/MPG.0000000000002028. Troendle DM, Fishman DS, Barth BA, Giefer MJ, Lin TK, Liu QY, Abu-El-Haija M, Bellin MD, Durie PR, Freedman SD, Gariepy C, Gonska T, Heyman MB, Himes R, Husain SZ, Kumar S, Lowe ME, Morinville VD, Ooi CY, Palermo J, Pohl JF, Schwarzenberg SJ, Werlin S, Wilschanski M, Zimmerman MB, Uc A. Therapeutic Endoscopic Retrograde Cholangiopancreatography in Pediatric Patients With Acute Recurrent and Chronic Pancreatitis: Data From the INSPPIRE (INternational Study group of Pediatric Pancreatitis: In search for a cuRE) Study. Pancreas. 2017 Jul;46(6):764-769. doi: 10.1097/MPA.0000000000000848. Scheers I, Palermo JJ, Freedman S, Wilschanski M, Shah U, Abu-El-Haija M, Barth B, Fishman DS, Gariepy C, Giefer MJ, Heyman MB, Himes RW, Husain SZ, Lin TK, Liu Q, Lowe M, Mascarenhas M, Morinville V, Ooi CY, Perito ER, Piccoli DA, Pohl JF, Schwarzenberg SJ, Troendle D, Werlin S, Zimmerman B, Uc A, Gonska T. Autoimmune Pancreatitis in Children: Characteristic Features, Diagnosis, and Management. Am J Gastroenterol. 2017 Oct;112(10):1604-1611. doi: 10.1038/ajg.2017.85. Epub 2017 Apr 4. Schwarzenberg SJ, Bellin M, Husain SZ, Ahuja M, Barth B, Davis H, Durie PR, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Heyman MB, Himes R, Kumar S, Morinville VD, Lowe ME, Nuehring NE, Ooi CY, Pohl JF, Troendle D, Werlin SL, Wilschanski M, Yen E, Uc A. Pediatric chronic pancreatitis is associated with genetic risk factors and substantial disease burden. J Pediatr. 2015 Apr;166(4):890-896.e1. doi: 10.1016/j.jpeds.2014.11.019. Epub 2014 Dec 30. Ting J, Wilson L, Schwarzenberg SJ, Himes R, Barth B, Bellin MD, Durie PR, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Husain SZ, Kumar S, Morinville VD, Lowe ME, Ooi CY, Pohl JF, Troendle D, Usatin D, Werlin SL, Wilschanski M, Heyman MB, Uc A. Direct Costs of Acute Recurrent and Chronic Pancreatitis in Children in the INSPPIRE Registry. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):443-9. doi: 10.1097/MPG.0000000000001057.
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Public notes
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Contacts
Principal investigator
Name
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Ying Yuan, Ph.D
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Address
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MD Anderson
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Country
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Gariepy CE, Heyman MB, Lowe ME, Pohl JF, Werlin SL...
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Giefer MJ, Lowe ME, Werlin SL, Zimmerman B, Wilsch...
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Husain SZ, Morinville V, Pohl J, Abu-El-Haija M, B...
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Kumar S, Ooi CY, Werlin S, Abu-El-Haija M, Barth B...
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Lin TK, Abu-El-Haija M, Nathan JD, Palermo JP, Bar...
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Pohl J, Morinville V, Husain SZ, Uc A. Toxic-Metab...
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Scheers I, Palermo JJ, Freedman S, Wilschanski M, ...
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Troendle DM, Fishman DS, Barth BA, Giefer MJ, Lin ...
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Scheers I, Palermo JJ, Freedman S, Wilschanski M, ...
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Schwarzenberg SJ, Bellin M, Husain SZ, Ahuja M, Ba...
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Ting J, Wilson L, Schwarzenberg SJ, Himes R, Barth...
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Results not provided in
https://clinicaltrials.gov/study/NCT03672422