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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
  Purpose
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).

Condition Intervention
Pancreatitis Other: Data Management and Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Specimens collected at participating sites.

Estimated Enrollment: 860
Actual Study Start Date: March 16, 2017
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pediatric Chronic 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.


  Eligibility

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 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from external sites.
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 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.

  Contacts and Locations
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): NCT03081182


Contacts
Contact: Ziding Feng, PHD 713-563-4276 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ziding Feng, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03081182     History of Changes
Other Study ID Numbers: PA17-0107
1U01DK108328-01 ( U.S. NIH Grant/Contract )
First Submitted: March 2, 2017
First Posted: March 16, 2017
Last Update Posted: April 21, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Pediatric Chronic Pancreatitis
Data management
Regulatory compliance
Protocol monitoring

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases