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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
Scientific title
Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
Secondary ID [1] 0 0
3U01DK108334
Secondary ID [2] 0 0
201705709
Universal Trial Number (UTN)
Trial acronym
INSPPIRE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatitis, Chronic 0 0
Pancreatitis, Acute 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of time from progression from Acute Recurrent Pancreatitis to Chronic Pancreatitis
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Number of subjects with abdominal pain
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Number of subjects with constant abdominal pain
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Number of subjects with episodic abdominal pain
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Number of emergency room visits subject had in the past 12 months
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Number of emergency room visits subject had in whole life
Timepoint [5] 0 0
18 years
Secondary outcome [6] 0 0
Number of hospitalizations subject had in past 12 months
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Number of hospitalizations subject had in whole life
Timepoint [7] 0 0
18 years
Secondary outcome [8] 0 0
Number of school days subject missed in the last month
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Number of subjects with Exocrine Pancreatic Insufficiency
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Number of subjects with abnormal fasting glucose
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
Number of subjects with abnormal hemoglobin A1c (HbA1c)
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Number of subjects with abnormal oral glucose tolerance test (OGTT)
Timepoint [12] 0 0
3 years

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).
Minimum age
0 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2020
Sample size
Target
Accrual to date
Final
623
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital Randwick - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Israel
State/province [15] 0 0
Jerusalem

Funding & Sponsors
Primary sponsor type
Other
Name
Aliye Uc
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ying Yuan, Ph.D
Address 0 0
MD Anderson
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Gariepy CE, Heyman MB, Lowe ME, Pohl JF, Werlin SL... [More Details]
Journal Giefer MJ, Lowe ME, Werlin SL, Zimmerman B, Wilsch... [More Details]
Journal Husain SZ, Morinville V, Pohl J, Abu-El-Haija M, B... [More Details]
Journal Kumar S, Ooi CY, Werlin S, Abu-El-Haija M, Barth B... [More Details]
Journal Lin TK, Abu-El-Haija M, Nathan JD, Palermo JP, Bar... [More Details]
Journal Pohl J, Morinville V, Husain SZ, Uc A. Toxic-Metab... [More Details]
Journal Scheers I, Palermo JJ, Freedman S, Wilschanski M, ... [More Details]
Journal Troendle DM, Fishman DS, Barth BA, Giefer MJ, Lin ... [More Details]
Journal Scheers I, Palermo JJ, Freedman S, Wilschanski M, ... [More Details]
Journal Schwarzenberg SJ, Bellin M, Husain SZ, Ahuja M, Ba... [More Details]
Journal Ting J, Wilson L, Schwarzenberg SJ, Himes R, Barth... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03672422