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Pediatric Longitudinal Cohort Study of Chronic Pancreatitis

This study is currently recruiting participants.
Verified April 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03081182
First Posted: March 16, 2017
Last Update Posted: April 21, 2017
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.
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
March 2, 2017
March 16, 2017
April 21, 2017
March 16, 2017
March 2022   (Final data collection date for primary outcome measure)
Compliance Monitoring of Regulatory Documents for Consortium Study of Pediatric Chronic Pancreatitis [ Time Frame: 5 years ]
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will monitor regulatory compliance at all participating institutions.
Same as current
Complete list of historical versions of study NCT03081182 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis
Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)
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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Specimens collected at participating sites.
Non-Probability Sample
Participants recruited from external sites.
Pancreatitis
Other: Data Management and Monitoring

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer 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.

Pediatric Chronic Pancreatitis
Intervention: Other: Data Management and Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
860
March 2022
March 2022   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact: Ziding Feng, PHD 713-563-4276 CR_Study_Registration@mdanderson.org
United States
 
 
NCT03081182
PA17-0107
1U01DK108328-01 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ziding Feng, PHD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2017