<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/NCT03267875</url>
  </required_header>
  <id_info>
    <org_study_id>Aneurysm-IgG4</org_study_id>
    <nct_id>NCT03267875</nct_id>
  </id_info>
  <brief_title>A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood</brief_title>
  <official_title>A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of&#xD;
      recently discovered medical conditions.&#xD;
&#xD;
      The properties that bind them are: lesions similar to tumors in the mixed organs,&#xD;
      lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and&#xD;
      often, but not always, a high level of IgG4 in the serum.&#xD;
&#xD;
      This disease has been on the rise for the past two decades and since its recognition in 2001&#xD;
      there has been impressive progress in understanding its various manifestations, so that today&#xD;
      almost every body system can be involved.&#xD;
&#xD;
      One of the conditions associated with this disease is oritis / periortitis and aneurysms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of&#xD;
      recently discovered medical conditions.&#xD;
&#xD;
      The properties that bind them are: lesions similar to tumors in the mixed organs,&#xD;
      lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and&#xD;
      often, but not always, a high level of IgG4 in the serum.&#xD;
&#xD;
      This disease has been on the rise for the past two decades and since its recognition in 2001&#xD;
      there has been impressive progress in understanding its various manifestations, so that today&#xD;
      almost every body system can be involved.&#xD;
&#xD;
      One of the conditions associated with this disease is oritis / periortitis and aneurysms&#xD;
&#xD;
      It is common to divide the aortic aneurysms according to the following etiologies:&#xD;
&#xD;
        1. Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether&#xD;
           IgG4RD is related / not related.&#xD;
&#xD;
        2. Atherosclerotic infrastructure.&#xD;
&#xD;
      Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and&#xD;
      adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In&#xD;
      addition, the laboratory findings are usually white counts and increased CRP.&#xD;
&#xD;
      In this context, the investigators will examine the level of IgG4 in the blood of a&#xD;
      population of patients with aortic aneurysms and try to understand the proportion of patients&#xD;
      whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related&#xD;
      Disease.&#xD;
&#xD;
      the investigator chose the blood IgG4 level because it is the most important diagnostic&#xD;
      variable for the disease (it is customary to place the incision point at &gt; 135mg / dL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 8, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IgG4 Level</measure>
    <time_frame>1 year</time_frame>
    <description>count IgG4 Level to figure if its IgG4-related disease</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>IgG4-related Disease</condition>
  <condition>Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients after aneurysm in the aorta, Men and women aged 18-100 (not including special populations), who are able to read understand and sign a written consent to participate in the research</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Test</intervention_name>
    <description>draw out 2 blood tubes from a patient</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients after aneurysm in the aorta&#xD;
&#xD;
          -  Men and women aged 18-100 (not including special populations)&#xD;
&#xD;
          -  Those who are able to read understand and sign a written consent to participate in the&#xD;
             research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient who does not meet the inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>male and female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yael Eizikovits, B.A</last_name>
    <role>Study Chair</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eran Levi, EMT-P</last_name>
    <phone>+972-9-7471936</phone>
    <email>eran.levi@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yfat Buhbut, B.sc</last_name>
    <phone>+972-9-7471936</phone>
    <email>yfat.buhbut@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yael Eizikovits</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>yair levy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Immunoglobulin G4-Related Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03267875
org study id: Aneurysm-IgG4
nct id: NCT03267875
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of
      recently discovered medical conditions.

      The properties that bind them are: lesions similar to tumors in the mixed organs,
      lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and
      often, but not always, a high level of IgG4 in the serum.

      This disease has been on the rise for the past two decades and since its recognition in 2001
      there has been impressive progress in understanding its various manifestations, so that today
      almost every body system can be involved.

      One of the conditions associated with this disease is oritis / periortitis and aneurysms
IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of
      recently discovered medical conditions.

      The properties that bind them are: lesions similar to tumors in the mixed organs,
      lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and
      often, but not always, a high level of IgG4 in the serum.

      This disease has been on the rise for the past two decades and since its recognition in 2001
      there has been impressive progress in understanding its various manifestations, so that today
      almost every body system can be involved.

      One of the conditions associated with this disease is oritis / periortitis and aneurysms

      It is common to divide the aortic aneurysms according to the following etiologies:

        1. Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether
           IgG4RD is related / not related.

        2. Atherosclerotic infrastructure.

      Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and
      adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In
      addition, the laboratory findings are usually white counts and increased CRP.

      In this context, the investigators will examine the level of IgG4 in the blood of a
      population of patients with aortic aneurysms and try to understand the proportion of patients
      whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related
      Disease.

      the investigator chose the blood IgG4 level because it is the most important diagnostic
      variable for the disease (it is customary to place the incision point at > 135mg / dL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: IgG4 Level
time frame: 1 year
description: count IgG4 Level to figure if its IgG4-related disease
arm group label: single arm
arm group type: Experimental
description: Patients after aneurysm in the aorta, Men and women aged 18-100 (not including special populations), who are able to read understand and sign a written consent to participate in the research
intervention type: Procedure
intervention name: Blood Test
description: draw out 2 blood tubes from a patient
arm group label: single arm
criteria: 
gender: All
gender based: Yes
gender description: male and female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Yael Eizikovits, B.A
role: Study Chair
affiliation: Meir Medical Center
last name: Eran Levi, EMT-P
phone: +972-9-7471936
email: eran.levi@clalit.org.il
last name: Yfat Buhbut, B.sc
phone: +972-9-7471936
email: yfat.buhbut@clalit.org.il
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: yair levy
investigator title: Professor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Immunoglobulin G4-Related Disease
sharing ipd: Undecided