ClinicalTrials.gov
ClinicalTrials.gov Menu

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 14, 2018
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 860 patients under 18 years of age with ARP or CP. Included in the total are the 502 patients 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

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 860 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 or 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.

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 or 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.




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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Show 22 Study Locations
Sponsors and Collaborators
Aliye Uc
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
Investigators
Study Director: Ying Yuan, Ph.D MD Anderson

Additional Information:
Publications of Results:

Other Publications:

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

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:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases