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Trial record 21 of 628 for:    pancreatitis

PROOF: Pancreatitis-associated Risk Of Organ Failure (PROOF)

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ClinicalTrials.gov Identifier: NCT03075605
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Georgios Papachristou, University of Pittsburgh

Brief Summary:
This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis.

Condition or disease
Pancreatitis Organ Failure, Multiple

Detailed Description:
This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis. Therefore, the investigators aim to determine whether etiology of acute pancreatitis, segregates with candidate genetic polymorphisms and their m-RNA expression, as well as whether functional polymorphisms in inflammation regulating genes predict a more severe outcome in acute pancreatits. The investigators anticipate that based on our results that we will provide a more accurate predictor of the clinical course of acute pancreatits and help direct more aggressive or cytokine specific treatment of patients at greater risk of a more severe form of the disease.

Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROOF: Pancreatitis-associated Risk Of Organ Failure
Actual Study Start Date : May 20, 2008
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Group/Cohort
Subjects with acute pancreatitis
Subjects with acute pancreatitis
Subjects with previous attack
Subjects with previous attack
Controls
Controls



Primary Outcome Measures :
  1. Severe Acute Pancreatitis (defined as persistent organ failure) [ Time Frame: 1 year ]
    To compare the initial immune response in patients who developed mild vs. severe disease. To determine whether functional polymorphisms in inflammation regulating genes predicts a more severe outcome in acute pancreatitis.


Biospecimen Retention:   Samples With DNA
Serum and DNA and urine samples will be collected and stored without personal identifiers (e.g. using a unique laboratory number or bar code) for future research involving pancreatic diseases to include pancreatitis and pancreatic cancer. Stored biospecimens collected for htis protocol may be shared in a de-identified manner with outside investigators with the approval of the principal investigator.


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Both males and females, over 1 year of age.
Criteria

Inclusion Criteria:

  • Inclusion criteria for Subjects (all three) Males and females of 16 years of age and older. Body weight at least 40kg

Diagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND Elevated amylase levels by at-least three times the upper limit of normal and/or elevated lipase levels by at-least three times the upper limit of normal (25, 26). Acute pancreatitis must be defined by 2 of the 3 following criteria:

  • Serum amylase or lipase elevated greater than 3X upper limit of normal
  • epigastric acute pancreatitis pain
  • abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis Willingness to participate in the study and sign the informed consent. (Children and subjects who are cognitively impaired for temporary reasons as mentioned in the section 4.7 of this protocol will require a representative to sign the informed consent).

Inclusion criteria for Controls (all three) Males and females of 18 years of age and older. a. Unrelated family member or a friend of the subject or a patient having blood drawn in general medicine outpatient clinic, without a history of pancreatitis, OR Willingness to participate in the study and sign the informed consent.

Additional Inclusion Criteria for subjects with a previous attack of acute pancreatitis:

age criteria as defined above.

- Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48 hours or evidence of pancreatic necrosis on computerized tomography.

Willingness to participate and sign informed consent

Exclusion Criteria:

  • Exclusion Criteria for Subjects:

Persons unwilling to sign the informed consent Disorientation secondary to irreversible organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.

Blood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic cancer History of cancer requiring chemotherapy or radiation within the past 1 year History of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical complications

Exclusion criteria for Controls:

Persons unwilling to sign the informed consent


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): NCT03075605


Contacts
Contact: Georgios I Papachristou, MD 412-647-8132 papachri@pitt.edu
Contact: Emily C Baehr, BA 412-648-5652 ecb42@pitt.edu

Locations
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Georgios I Papachristou, MD    412-647-8132    papachri@pitt.edu   
Contact: Emily C Baehr, BA    412-648-5652 ext Baehr    ecb42@pitt.edu   
Principal Investigator: Georgios I Papachristou, MD         
Sponsors and Collaborators
University of Pittsburgh

Responsible Party: Georgios Papachristou, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03075605     History of Changes
Other Study ID Numbers: PRO08010374
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If shared, all individual identifiers will be removed.

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

Additional relevant MeSH terms:
Pancreatitis
Multiple Organ Failure
Pancreatic Diseases
Digestive System Diseases
Shock
Pathologic Processes