<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830073</url>
  </required_header>
  <id_info>
    <org_study_id>Autoimmune pancreatitis</org_study_id>
    <nct_id>NCT03830073</nct_id>
  </id_info>
  <brief_title>Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene</brief_title>
  <official_title>Assessment of the Different Etiological and Susceptibility Markers in Patients With Pancreatitis: Investigating IG4, Cytomegalovirus, Coxsackie- Virus, Genetic Polymorphism of Vitamin D Receptor Gene</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute pancreatitis (AP) is a multifactorial disease. AP represents a significant number of&#xD;
      hospital admissions. Most of the patients are admitted in an acute setting. Early&#xD;
      identification of its etiology is an essential step toward the rational approach, both for&#xD;
      its implications in the immediate therapy and the prevention of recurrence. Although often&#xD;
      obvious, the etiological workup of acute pancreatitis can be challenging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a&#xD;
      benign disease, it often progresses to a serious state, and mortality is still high.&#xD;
      Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing&#xD;
      of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear&#xD;
      antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main&#xD;
      differential diagnosis is pancreatic cancer, which can be ruled out through radiological,&#xD;
      serological, and histological investigations.&#xD;
&#xD;
      Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a&#xD;
      cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100%&#xD;
      but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and&#xD;
      self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection&#xD;
      typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum&#xD;
      transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection&#xD;
      can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and&#xD;
      pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.&#xD;
&#xD;
      VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining&#xD;
      normal insulin levels in accordance to glucose concentrations and to maintain glucose&#xD;
      tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality,&#xD;
      e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on&#xD;
      the balance in the vitamin D concentration in the circulation, and the final metabolite&#xD;
      activity throughout the body.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls</measure>
    <time_frame>Baseline</time_frame>
    <description>Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Group I:</arm_group_label>
    <description>Seventy patients with pancreatitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II:</arm_group_label>
    <description>Thirty healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Measurement of VDR genetic polymorphism</intervention_name>
    <description>VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.</description>
    <arm_group_label>Group I:</arm_group_label>
    <arm_group_label>Group II:</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute pancreatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a confirmed diagnosis of acute pancreatitis.&#xD;
&#xD;
          -  Patients of age 20 years or more who are willing to participate in the study and give&#xD;
             their consent for same.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with a history of severe liver disease,&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  Chest disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>reham elmahdy</last_name>
    <phone>+201002714637</phone>
    <email>reham.elmahdy@aun.edu.eg</email>
  </overall_contact>
  <reference>
    <citation>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.</citation>
    <PMID>29966312</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24940147</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27171510</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1318913</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Reham I El-mahdy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cytomegalovirus</keyword>
  <keyword>Coxsackie- virus</keyword>
  <keyword>Vitamin D receptor gene</keyword>
  <keyword>IG4</keyword>
  <keyword>Autoimmune pancreatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coxsackievirus Infections</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830073
org study id: Autoimmune pancreatitis
nct id: NCT03830073
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
Acute pancreatitis is the most common pancreatic disorder. Although acute pancreatitis is a
      benign disease, it often progresses to a serious state, and mortality is still high.
      Autoimmune pancreatitis (AIP) was first used to describe cases of pancreatitis with narrowing
      of the pancreatic duct, enlargement of the pancreas, hyper-γ-globulinaemia, and antinuclear
      antibody (ANA) positivity serologically by indirect immunofluorescence (IIF). The main
      differential diagnosis is pancreatic cancer, which can be ruled out through radiological,
      serological, and histological investigations.

      Cytomegalovirus (CMV) is a common viral pathogen in humans. It is a lytic virus that causes a
      cytopathic effect in vitro and in vivo. Seroprevalence for CMV worldwide ranges from 60%-100%
      but the severity of illness varies. Primary CMV may be asymptomatic or may cause a mild and
      self-limiting mononucleosis-like syndrome. The self-limiting course of CMV infection
      typically includes fever, malaise, splenomegaly, mild hepatomegaly, small increases in serum
      transaminase activity, and variable elevation of serum alkaline phosphatase. CMV infection
      can cause severe hepatitis, meningitis, encephalitis, myelitis, colitis, pancreatitis and
      pneumonitis. Coxsackie-B virus can also cause acute pancreatitis.

      VDR are also expressed on pancreatic Ɓ cells, and may play an essential role in maintaining
      normal insulin levels in accordance to glucose concentrations and to maintain glucose
      tolerance. Because vitamin D acts through VDR, their impairment or reduced functionality,
      e.g., as a result of polymorphisms occurring in the VDR gene, may have a crucial impact on
      the balance in the vitamin D concentration in the circulation, and the final metabolite
      activity throughout the body.
observational model: Case-Control
time perspective: Cross-Sectional
measure: The mean difference of single nucleotide polymorphism of VDR between pancreatitis patients and healthy controls
time frame: Baseline
description: Single nucleotide polymorphism of VDR mean difference will be measured by restriction fragment length polymorphism.
arm group label: Group I:
description: Seventy patients with pancreatitis
arm group label: Group II:
description: Thirty healthy controls
intervention type: Genetic
intervention name: Measurement of VDR genetic polymorphism
description: VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.
arm group label: Group I:
arm group label: Group II:
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: reham elmahdy
phone: +201002714637
email: reham.elmahdy@aun.edu.eg
citation: 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: 29966312
citation: 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: 24940147
citation: 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: 27171510
citation: 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: 1318913
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Reham I El-mahdy
investigator title: Principal Investigator
mesh term: Coxsackievirus Infections
mesh term: Pancreatitis