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Predicting Pancreatic Necrosis Using mitDNA

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. Identifier: NCT03788928
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Information provided by (Responsible Party):
Soha Mohammad Nageb, Assiut University

Brief Summary:
Multiple predictors have been used for early pancreatic necrosis, prediction, detection, and monitoring. These include clinical score systems and circulating biomarkers. Ranson and APACHE II score systems are widely used albeit complex and time-consuming. Recently, the role of circulating biomarkers . Of these novel biomarkers, only CRP has been used routinely in cases of pancreatic necrosis prediction. Mitochondrial DNA (mtDNA) is an extra chromosomal genome occurring in the mitochondria of eukaryotic cells. High levels of mtDNA suggest the presence of pancreatic necrosis and close observation should be given to avoid the development of SAP and pancreatitis infection.

Condition or disease Intervention/treatment
Pancreatic Necrosis Diagnostic Test: serum mitochondrial DNA

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of Plasma mitDNA in Predicting Pancreatic Necrosis in Acute Pancreatitis
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Intervention Details:
  • Diagnostic Test: serum mitochondrial DNA
    serum mitochondrial DNA will be measured using RT-PCR within first 72 hours of symptoms of acute pancreatitis

Primary Outcome Measures :
  1. level of serum mitochondrial DNA [ Time Frame: baseline ]
    level of serum mitochondrial DNA in severe acute pancreatitis

Biospecimen Retention:   Samples With DNA
Mitochondrial dna serum using qt_PCR

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be enrolled from Raghi hospital ,Assiut university who will be diagnosed with acute pancreatitis

Inclusion Criteria:

  • all patients diagnosed as acute pancreatitis using elevated serum amylase and contrast enhanced CT scan.

Exclusion Criteria:

  • Alchoholics
  • Renal impairment

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 identifier (NCT number): NCT03788928

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Contact: Mostafa Abdul-Allah Haredi, Professor +201001079913
Contact: Dr. Muhammad Abbas Said El-Masry, assistant prof. +201272196319

Sponsors and Collaborators
Assiut University

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Responsible Party: Soha Mohammad Nageb, spechialist, Assiut University Identifier: NCT03788928     History of Changes
Other Study ID Numbers: mitDNA in acute pancreatitis
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes