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Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis (DIAGNON)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634787
Recruitment Status : Unknown
Verified August 2018 by Aiste Gulla, Vilnius University.
Recruitment status was:  Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Aiste Gulla, Vilnius University

Study Description
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Brief Summary:

To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis.

All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.


Condition or disease Intervention/treatment
Acute Pancreatitis Diagnostic Test: CT Scan Day 5-7

Detailed Description:

All patients with acute pancreatitis are evaluated according to modified Atlanta classification acute pancreatitis severity scores.

Blood serum, urine and DNA samples are collected from all patients presented on admission, after 24 hours, 48 hours, 72 hours.

CT is performed in al patients to evaluate necrosis of pancreas Day 5-7 since hospital admission. If necrosis is not present follow-up is stopped.

Study Design
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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis Shock

Groups and Cohorts
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Group/Cohort Intervention/treatment
Acute pancreatitis
First time acute pancreatitis. No later than 2 days since the clinical symptoms started.
 Diagnostic Test: CT Scan Day 5-7
Computed Tomography on Day 5-7 according to a clinical protocol.
Healthy
No major systemic illness


Outcome Measures
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Primary Outcome Measures :
  1. To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings [ Time Frame: 2 years ]
    Different molecular weight Heat Shock proteins role while developing acute pancreatitis.


Secondary Outcome Measures :
  1. To measure pancreas cells activity while applying Heat Shock Protein inhibitors [ Time Frame: 2 years ]
    To establish a mechanism explaining the potential use of heat shock proteins inhibitors/ activators for treatment of acute pancreatitis


Biospecimen Retention:   Samples With DNA
Blood and urine samples on admission

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis
Criteria

Inclusion Criteria:

  • no prior diagnosis of acute pancreatitis
  • admission to the hospital within 2 days since the clinical symptoms
  • confirmed diagnosis of acute pancreatitis

Exclusion Criteria:

  • chronic pancreatitis
  • pancreatic cancer
Contacts and Locations
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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): NCT03634787


Contacts
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Contact: Kestutis Strupas, Prof. MD/PhD +37052365000 kestutis.strupas@santa.lt
Contact: Aiste Gulla, MD +37052365000 aiste.kielaite-gulla@santa.lt

Locations
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Lithuania
Vilnius University Hospital "Santaros Klinikos Recruiting
Vilnius, Lithuania, 08410
Contact: Kestutis Strupas, Prof.MD/PhD    +3705236500    kestutis.strupas@santa.lt   
Contact: Aiste Gulla, MD    +37052365000    aiste.kielaite-gulla@santa.lt   
Principal Investigator: Kestutis Strupas, Prof. MD/phD         
Sub-Investigator: Aiste Gulla, MD         
Sponsors and Collaborators
Vilnius University
More Information
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Responsible Party: Aiste Gulla, Senior surgery resident, Vilnius University
ClinicalTrials.gov Identifier: NCT03634787    
Other Study ID Numbers: 158200-17-941-455
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share the data and recruitment status when the study reaches its requirement sample size

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aiste Gulla, Vilnius University:
Heat Shock Proteins, early diagnosis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases