NCT03788928

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 28, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 25, 2018

Last Update Submit

December 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • level of serum mitochondrial DNA

    level of serum mitochondrial DNA in severe acute pancreatitis

    baseline

Interventions

serum mitochondrial DNA will be measured using RT-PCR within first 72 hours of symptoms of acute pancreatitis

Eligibility Criteria

Age16 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be enrolled from Raghi hospital ,Assiut university who will be diagnosed with acute pancreatitis

You may qualify if:

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

You may not qualify if:

  • Alchoholics
  • Renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wu L, Xu W, Wang F, Lv T, Yin Z, Song Y. Plasma mtDNA Analysis Aids in Predicting Pancreatic Necrosis in Acute Pancreatitis Patients: A Pilot Study. Dig Dis Sci. 2018 Nov;63(11):2975-2982. doi: 10.1007/s10620-018-5227-9. Epub 2018 Aug 9.

    PMID: 30094625BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Mitochondrial dna serum using qt\_PCR

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Central Study Contacts

Mostafa Abdul-Allah Haredi, Professor

CONTACT

Dr. Muhammad Abbas Said El-Masry, assistant prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
spechialist

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 28, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 1, 2020

Last Updated

December 28, 2018

Record last verified: 2018-12