Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

Pancreatitis Clinical Trial

Official title:

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03081182
• Other study ID #: PA17-0107
• Secondary ID: 1U01DK108328-01
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2017
• Last updated: February 19, 2018
• Start date: March 16, 2017
• Est. completion date: March 2023

Study information

• Verified date: February 2018
• Source: M.D. Anderson Cancer Center
• Contact: Ziding Feng, PHD
• Phone: 713-563-4276
• Email: CR_Study_Registration[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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 18 y/o or younger 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, 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 and

ONE of the two conditions below:

2. exocrine pancreatic insufficiency

3. 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:

1. 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.

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• Data Management and Monitoring
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for all consortium studies. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance Monitoring of Regulatory Documents for Consortium Study of Pediatric Chronic Pancreatitis	The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor regulatory compliance at all participating institutions.	5 years

External Links

•   University of Texas MD Anderson Cancer Center Website