NCT03830073

Brief Summary

Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of hospital admissions. Most of the patients are admitted in an acute setting. Early identification of its etiology is an essential step toward the rational approach, both for its implications in the immediate therapy and the prevention of recurrence. Although often obvious, the etiological workup of acute pancreatitis can be challenging.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 2, 2019

Last Update Submit

February 2, 2019

Conditions

Acute Pancreatitis

Keywords

CytomegalovirusCoxsackie- virusVitamin D receptor geneIG4Autoimmune pancreatitis

Outcome Measures

Primary Outcomes (1)

  • The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls

    Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.

    Baseline

Study Arms (2)

Group I:

Seventy patients with pancreatitis

Genetic: Measurement of VDR genetic polymorphism

Group II:

Thirty healthy controls

Genetic: Measurement of VDR genetic polymorphism

Interventions

Measurement of VDR genetic polymorphismGENETIC

VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.

Group I:Group II:

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Acute pancreatitis

You may qualify if:

  • Patients with a confirmed diagnosis of acute pancreatitis.
  • Patients of age 20 years or more who are willing to participate in the study and give their consent for same.

You may not qualify if:

  • with a history of severe liver disease,
  • sepsis
  • Chest disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Cieslinska A, Kostyra E, Fiedorowicz E, Snarska J, Kordulewska N, Kiper K, Savelkoul HFJ. Single Nucleotide Polymorphisms in the Vitamin D Receptor Gene (VDR) May Have an Impact on Acute Pancreatitis (AP) Development: A Prospective Study in Populations of AP Patients and Alcohol-Abuse Controls. Int J Mol Sci. 2018 Jun 29;19(7):1919. doi: 10.3390/ijms19071919.

    PMID: 29966312BACKGROUND

  • Chan A, Bazerbachi F, Hanson B, Alraies MC, Duran-Nelson A. Cytomegalovirus hepatitis and pancreatitis in the immunocompetent. Ochsner J. 2014 Summer;14(2):295-9.

    PMID: 24940147BACKGROUND

  • Shimizu K, Tahara J, Takayama Y, Akao J, Ajihara T, Nagao K, Shiratori K, Tokushige K. Assessment of the Rate of Decrease in Serum IgG4 Level of Autoimmune Pancreatitis Patients in Response to Initial Steroid Therapy as a Predictor of Subsequent Relapse. Pancreas. 2016 Oct;45(9):1341-6. doi: 10.1097/MPA.0000000000000633.

    PMID: 27171510BACKGROUND

  • Ozsvar Z, Deak J, Pap A. Possible role of Coxsackie-B virus infection in pancreatitis. Int J Pancreatol. 1992 Apr;11(2):105-8. doi: 10.1007/BF02925981.

    PMID: 1318913BACKGROUND

MeSH Terms

Conditions

PancreatitisCoxsackievirus InfectionsAutoimmune Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPancreatitis, ChronicAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

reham elmahdy

CONTACT

+201002714637reham.elmahdy@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

March 1, 2019

Primary Completion

June 1, 2019

Study Completion

June 20, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02