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Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672422
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Aliye Uc, University of Iowa

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.

Condition or disease Intervention/treatment
Pancreatitis, Chronic Pancreatitis, Acute Diagnostic Test: Blood sample Behavioral: Patient questionnaires Diagnostic Test: Saliva sample Diagnostic Test: Urine sample

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 628 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort Intervention/treatment
Acute Recurrent Pancreatitis
At least 2 episodes of acute pancreatitis with complete resolution of pain and a >1 month pain-free interval between episodes.
Diagnostic Test: 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.

Diagnostic Test: Saliva sample
2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected.

Diagnostic Test: Urine sample
50 ml of urine in collection container.

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).
Diagnostic Test: 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.

Diagnostic Test: Saliva sample
2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected.

Diagnostic Test: Urine sample
50 ml of urine in collection container.




Primary Outcome Measures :
  1. Length of time from progression from Acute Recurrent Pancreatitis to Chronic Pancreatitis [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Number of subjects with abdominal pain [ Time Frame: 1 year ]
    Presence of abdominal pain in the past year presented as number with "Yes", "No", "I don't know" and missing responses.

  2. Number of subjects with constant abdominal pain [ Time Frame: 1 year ]
    Presence of constant abdominal pain described as number of subjects with "Yes", "No", "I don't know" and missing responses.

  3. Number of subjects with episodic abdominal pain [ Time Frame: 1 year ]
    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..

  4. Number of emergency room visits subject had in the past 12 months [ Time Frame: 1 year ]
    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.

  5. Number of emergency room visits subject had in whole life [ Time Frame: 18 years ]
    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..

  6. Number of hospitalizations subject had in past 12 months [ Time Frame: 1 year ]
    Number of hospitalizations subject experienced in the past 12 months presented as minimum, maximum, and median number and number of missing responses..

  7. Number of hospitalizations subject had in whole life [ Time Frame: 18 years ]
    Number of hospitalizations subject had in their whole life presented as minimum, maximum, and median number and number of missing responses..

  8. Number of school days subject missed in the last month [ Time Frame: 30 days ]
    Number of school days subject missed in the last month presented as minimum, maximum, and median number and number of missing responses..

  9. Number of subjects with Exocrine Pancreatic Insufficiency [ Time Frame: 3 years ]
    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.

  10. Number of subjects with abnormal fasting glucose [ Time Frame: 3 years ]
    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.

  11. Number of subjects with abnormal hemoglobin A1c (HbA1c) [ Time Frame: 3 years ]
    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.

  12. Number of subjects with abnormal oral glucose tolerance test (OGTT) [ Time Frame: 3 years ]
    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.


Biospecimen Retention:   Samples With DNA
6 ml blood sample or 2 ml saliva sample collected 1 time. Urine 50 ml collected one time


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children <18 years of age with acute recurrent pancreatitis or chronic pancreatitis.
Criteria

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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672422


Contacts
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Contact: Aliye Uc, MD 319-384-6032 aliye-uc@uiowa.edu
Contact: Gretchen Cress, RN, MPH 319-353-4544 gretchen-cress@uiowa.edu

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Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Quin Liu, MD    323-361-2181    Quin.Liu@cshs.org   
Contact: Yunhee Choi-Kuaea    424-315-2543    Yunhee.Choi-Kuaea@cshs.org   
Principal Investigator: Quin Liu, MD         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Yuhua Zheng, MD    323-361-4456    yzhneg@chla.usc.edu   
Contact: Carly Weaver    323-361-8631    cweaver@chla.usc.edu   
Principal Investigator: Yuhua Zheng, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Emily Perito, MD    415-502-2159    emily.perito@ucsf.edu   
Contact: Melissa Zerofsky    415-502-6346    melissa.zerofsky@ucsf.edu   
Sub-Investigator: Mel Heyman, MD         
Principal Investigator: Emily Perito, MD         
Sub-Investigator: Sue Rhee, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Zachary Sellers, MD    858-752-8006    zsellers@stanford.edu   
Contact: Christina Vu    (650) 724-1336    ctvu@stanford.edu   
Principal Investigator: Zachary Sellers, MD         
Sub-Investigator: Walter Park, MD         
Sub-Investigator: Sohail Husain, MD         
United States, Indiana
Riley Hospital for Children Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brian McFerron, MD    317-944-9652    bmcferro@iu.edu   
Contact: Vanessa Patrick    317-948-4573    vpatrick@iu.edu   
Principal Investigator: Brian McFerron, MD         
United States, Iowa
University of Iowa Stead Family Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Aliye Uc, MD    319-384-6032    aliye-uc@uiowa.edu   
Contact: Gretchen Cress, RN, MPH    319-353-4544    gretchen-cress@uiowa.edu   
Principal Investigator: Aliye Uc, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Uzma Shah, MD    617-726-1450    Ushah@mgh.harvard.edu   
Contact: Ana Fernandes    617-724-2792    ADFernandes@mgh.harvard.edu   
Principal Investigator: Uzma Shah, MD         
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sarah Jane Schwarzenberg, MD    612-365-6777    schwa005@umn.edu   
Contact: Cathy Kneeland    612-626-4993    kreel001@umn.edu   
Principal Investigator: Sarah Jane Schwarzenberg, MD         
Sub-Investigator: Melena Bellin, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63112
Contact: Mark Lowe, MD    412-286-2784    lowe@wustl.edu   
Contact: Ashley Simpson    (314) 286-1550    ashley.simpson@wustl.edu   
Principal Investigator: Mark Lowe, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Maisam Abu El-Haija, MD    513-803-2123    Maisam.Haija@cchmc.org   
Contact: Tyler Thompson    (513) 517-1055    Tyler.Thompson@cchmc.org   
Principal Investigator: Maisam Abu El-Haija, MD         
Sub-Investigator: Jaimie Nathan, MD         
Sub-Investigator: Tom Lin, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Cheryl Gariepy, MD    614-722-3488    Cheryl.Gariepy@nationwidechildrens.org   
Contact: Fred Woodley, PhD       Frederick.Woodley@nationwidechildrens.org   
Principal Investigator: Cheryl Gariepy, MD         
Sub-Investigator: Ling Fan, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philipsburg, Pennsylvania, United States, 19104
Contact: Asim Maqbool, MD    215-590-3247    Maqbool@email.chop.edu   
Contact: Phoebe Wood    (267) 426-8411    WOODPM@email.chop.edu   
Principal Investigator: Asim Maqbool, MD         
Sub-Investigator: Maria Mascarenhas, MD         
Sub-Investigator: Sudha Anupindi, MD         
Sub-Investigator: Jefferson Brownell, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Kate Ellery, MD    412-692-5412    ellerykm@upmc.edu   
Contact: Adam Kufen, RN, MBA    412-692-6558    adam.kufen@chp.edu   
Sub-Investigator: Kate Ellery, MD         
Sub-Investigator: John Eisses, MD         
United States, Texas
Children's Health University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: David Troendle, MD       david.troendle@utsouthwestern.edu   
Contact: Susan Molle    214-456-8072    Susan.Molle@childrens.com   
Principal Investigator: David Troendle, MD         
Sub-Investigator: Bradley Barth, MD         
Sub-Investigator: Elaine Odiase, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Douglas Fishman, MD    832-822-1052    dougfishman@gmail.com   
Contact: Cynthia Tsai    832-822-3634    ct2@bcm.edu   
Principal Investigator: Douglas Fishman, MD         
Sub-Investigator: Ryan Himes, MD         
Sub-Investigator: Kristin Whitfield Van Buren, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84108
Contact: John Pohl, MD    801-662-1000    John.Pohl@hsc.utah.edu   
Contact: Alexander Plott-Koch       alesander.plott-koch@hsc.utah.edu   
Principal Investigator: John Pohl, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Matthew Giefer, MD    206-987-2165    matthew.giefer@seattlechildrens.org   
Contact: Stephanie Lammers    (206) 987-1062    Stephanie.Lammers@seattlechildrens.org   
Principal Investigator: Matthew Giefer, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Praveen Goday, MD    414-266-3690    pgoday@mcw.edu   
Contact: Kristen Lawrence    414-266-6131    klawrence@msw.edu   
Principal Investigator: Praveen Goday, MD         
Sub-Investigator: Ankur Chugh, MD         
Australia, New South Wales
Sydney Children's Hospital Randwick Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Keith Ooi, MD    +61 2 9382 5512    keith.ooi@unsw.edu.au   
Contact: Jessica Halim    +61 (2) 9382-5574    jessica.halim@unsw.edu.au   
Principal Investigator: Keith Ooi, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Tanja Gonska, MD    416-813-2164    tanja.gonska@sickkids.ca   
Contact: Katherine Keenan    416-8-3-5657    Katherine.Keenan@sickkids.ca   
Principal Investigator: Tanja Gonska, MD         
Canada, Quebec
Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Veronique Morinville, MD    514-412-4474    veronique.morinville@mcgill.ca   
Principal Investigator: Veronique Morinville, MD         
Israel
Hadassah University Hospital Mt. Scopus Recruiting
Jerusalem, Israel, 91240
Contact: Michael Wilschanski, MD    (+972)508573572    Michaelwil@hadassah.org.il   
Contact: Irina Rabkin    972-267-6709    irinar@hadassah.org.il   
Principal Investigator: Michael Wilschanski, MD         
Sponsors and Collaborators
Aliye Uc
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
Investigators
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Study Director: Ying Yuan, Ph.D MD Anderson

Additional Information:
Publications of Results:

Other Publications:

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Responsible Party: Aliye Uc, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03672422     History of Changes
Obsolete Identifiers: NCT03081182
Other Study ID Numbers: 201705709
3U01DK108334 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliye Uc, University of Iowa:
Pediatric
Pancreatitis
Chronic
Acute
Recurrent
ARP
CP
Pancreas
Children
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases